Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00763867
First received: September 30, 2008
Last updated: July 2, 2013
Last verified: July 2013
Results First Received: April 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Drug: Placebo
Drug: Sildenafil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Participant Flow:   Overall Study
    Placebo     Sildenafil  
STARTED     103     113  
COMPLETED     98     101  
NOT COMPLETED     5     12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil 20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Sildenafil     Total  
Number of Participants  
[units: participants]
  103     113     216  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     38     80  
>=65 years     61     75     136  
Age  
[units: years]
Mean ± Standard Deviation
  68.7  ± 10.1     68.4  ± 10.5     68.5  ± 10.3  
Gender  
[units: participants]
     
Female     55     49     104  
Male     48     64     112  
Region of Enrollment  
[units: participants]
     
United States     93     101     194  
Canada     10     12     22  



  Outcome Measures
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1.  Primary:   Exercise Capacity, as Determined by Peak Oxygen Uptake   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Primary
Measure Title Exercise Capacity, as Determined by Peak Oxygen Uptake
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  94     91  
Exercise Capacity, as Determined by Peak Oxygen Uptake  
[units: ml/min/kg]
Mean ± Standard Deviation
  -0.07  ± 2.00     -0.12  ± 2.29  

No statistical analysis provided for Exercise Capacity, as Determined by Peak Oxygen Uptake



2.  Secondary:   Exercise Capacity, as Determined by Peak Oxygen Uptake   [ Time Frame: Change from Baseline to Week 12 ]

Measure Type Secondary
Measure Title Exercise Capacity, as Determined by Peak Oxygen Uptake
Measure Description No text entered.
Time Frame Change from Baseline to Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  96     97  
Exercise Capacity, as Determined by Peak Oxygen Uptake  
[units: ml/min/kg]
Mean ± Standard Deviation
  0.02  ± 1.70     0.03  ± 2.20  

No statistical analysis provided for Exercise Capacity, as Determined by Peak Oxygen Uptake



3.  Secondary:   Exercise Capacity as Determined by Walk Distance   [ Time Frame: Change from Baseline to Week 12 ]

Measure Type Secondary
Measure Title Exercise Capacity as Determined by Walk Distance
Measure Description 6 Minute Walk Distance
Time Frame Change from Baseline to Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  96     99  
Exercise Capacity as Determined by Walk Distance  
[units: meters]
Mean ± Standard Deviation
  26.2  ± 83.7     5.2  ± 69.1  

No statistical analysis provided for Exercise Capacity as Determined by Walk Distance



4.  Secondary:   Composite Score Reflective of Clinical Status   [ Time Frame: Measured at Week 24 ]

Measure Type Secondary
Measure Title Composite Score Reflective of Clinical Status
Measure Description

Participants ranked sequentially with ranking stratified in one of three tiers based on:

  1. Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.
  2. Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.
  3. Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)

The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)

Time Frame Measured at Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  94     95  
Composite Score Reflective of Clinical Status  
[units: units on a scale]
Mean ± Standard Deviation
  95.8  ± 55.0     94.2  ± 54.6  

No statistical analysis provided for Composite Score Reflective of Clinical Status



5.  Secondary:   Exercise Capacity as Determined by Walk Distance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Secondary
Measure Title Exercise Capacity as Determined by Walk Distance
Measure Description 6 minute walk distance
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     90  
Exercise Capacity as Determined by Walk Distance  
[units: meters]
Mean ± Standard Deviation
  17.5  ± 88.6     12.0  ± 94.2  

No statistical analysis provided for Exercise Capacity as Determined by Walk Distance



6.  Secondary:   Cardiopulmonary Exercise Test (CPET) Duration   [ Time Frame: Change from Baseline to Week 12 ]

Measure Type Secondary
Measure Title Cardiopulmonary Exercise Test (CPET) Duration
Measure Description To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement
Time Frame Change from Baseline to Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  91     88  
Cardiopulmonary Exercise Test (CPET) Duration  
[units: minutes]
Mean ± Standard Deviation
  0.25  ± 1.61     -0.15  ± 1.60  

No statistical analysis provided for Cardiopulmonary Exercise Test (CPET) Duration



7.  Secondary:   Cardiopulmonary Exercise Test (CPET) Duration   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Secondary
Measure Title Cardiopulmonary Exercise Test (CPET) Duration
Measure Description To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  89     86  
Cardiopulmonary Exercise Test (CPET) Duration  
[units: minutes]
Mean ± Standard Deviation
  9.82  ± 2.63     9.77  ± 3.21  

No statistical analysis provided for Cardiopulmonary Exercise Test (CPET) Duration



8.  Secondary:   Ventilatory Anaerobic Threshold   [ Time Frame: Change from Baseline to Week 12 ]

Measure Type Secondary
Measure Title Ventilatory Anaerobic Threshold
Measure Description To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement
Time Frame Change from Baseline to Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  96     92  
Ventilatory Anaerobic Threshold  
[units: ml/min/kg]
Mean ± Standard Deviation
  -0.01  ± 1.14     0.06  ± 1.24  

No statistical analysis provided for Ventilatory Anaerobic Threshold



9.  Secondary:   Ventilatory Anaerobic Threshold   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Secondary
Measure Title Ventilatory Anaerobic Threshold
Measure Description To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  94     88  
Ventilatory Anaerobic Threshold  
[units: ml/min/kg]
Mean ± Standard Deviation
  -0.10  ± 1.26     0.17  ± 1.26  

No statistical analysis provided for Ventilatory Anaerobic Threshold



10.  Secondary:   Minnesota Living With Heart Failure Questionnaire (MLWHFQ)   [ Time Frame: Change from Baseline to Week 12 ]

Measure Type Secondary
Measure Title Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Measure Description

The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.

Total score: 0 – 105 Physical subscore: 0 – 40 Emotional subscore: 0 – 25

Time Frame Change from Baseline to Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  97     95  
Minnesota Living With Heart Failure Questionnaire (MLWHFQ)  
[units: units on a scale]
Mean ± Standard Deviation
  -8.3  ± 22.0     -6.2  ± 20.8  

No statistical analysis provided for Minnesota Living With Heart Failure Questionnaire (MLWHFQ)



11.  Secondary:   Minnesota Living With Heart Failure Questionnaire   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Secondary
Measure Title Minnesota Living With Heart Failure Questionnaire
Measure Description The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  91     91  
Minnesota Living With Heart Failure Questionnaire  
[units: units on a scale]
Mean ± Standard Deviation
  -9.2  ± 24.2     -8.3  ± 19.7  

No statistical analysis provided for Minnesota Living With Heart Failure Questionnaire



12.  Other Pre-specified:   MRI Left Ventricular Mass   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular Mass
Measure Description A decrease in LV Mass is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  47     49  
MRI Left Ventricular Mass  
[units: gm]
Mean ± Standard Deviation
  0.29  ± 14.43     -0.07  ± 14.93  

No statistical analysis provided for MRI Left Ventricular Mass



13.  Other Pre-specified:   MRI Left Ventricular Mass Index   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular Mass Index
Measure Description A decrease in Left Ventricular Mass Index is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  47     49  
MRI Left Ventricular Mass Index  
[units: gm/m^2]
Mean ± Standard Deviation
  0.47  ± 6.54     0.61  ± 6.96  

No statistical analysis provided for MRI Left Ventricular Mass Index



14.  Other Pre-specified:   MRI Left Ventricular End Diastolic Volume   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular End Diastolic Volume
Measure Description An increase in Left Ventricular End Diastolic Volume is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  103     113  
MRI Left Ventricular End Diastolic Volume  
[units: mL]
Mean ± Standard Deviation
  -3.70  ± 21.03     3.61  ± 25.02  

No statistical analysis provided for MRI Left Ventricular End Diastolic Volume



15.  Other Pre-specified:   MRI Left Ventricular End Diastolic Volume Index   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular End Diastolic Volume Index
Measure Description An increase in Left Ventricular End Diastolic Volume Index is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  47     49  
MRI Left Ventricular End Diastolic Volume Index  
[units: mL/m^2]
Mean ± Standard Deviation
  -1.73  ± 9.45     2.11  ± 11.21  

No statistical analysis provided for MRI Left Ventricular End Diastolic Volume Index



16.  Other Pre-specified:   MRI Left Ventricular End Systolic Volume Index   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular End Systolic Volume Index
Measure Description An increase in Left Ventricular End Systolic Volume Index is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  47     49  
MRI Left Ventricular End Systolic Volume Index  
[units: mL/m^2]
Mean ± Standard Deviation
  -0.82  ± 4.09     0.25  ± 6.12  

No statistical analysis provided for MRI Left Ventricular End Systolic Volume Index



17.  Other Pre-specified:   MRI Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Left Ventricular Ejection Fraction (LVEF)
Measure Description An increase in LVEF is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  47     49  
MRI Left Ventricular Ejection Fraction (LVEF)  
[units: percentage of volume]
Mean ± Standard Deviation
  0.55  ± 4.28     0.62  ± 4.88  

No statistical analysis provided for MRI Left Ventricular Ejection Fraction (LVEF)



18.  Other Pre-specified:   Echocardiogram Left Ventricular Mass   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Echocardiogram Left Ventricular Mass
Measure Description A decrease in Left Ventricular Mass is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  56     58  
Echocardiogram Left Ventricular Mass  
[units: gm]
Mean ± Standard Deviation
  -1.93  ± 47.36     -8.79  ± 35.60  

No statistical analysis provided for Echocardiogram Left Ventricular Mass



19.  Other Pre-specified:   Medial Diastolic Elastance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Medial Diastolic Elastance
Measure Description A decrease in Medial Diastolic Elastance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  72     68  
Medial Diastolic Elastance  
[units: (m/sec)/cc]
Mean ± Standard Deviation
  -0.03  ± 0.11     -0.01  ± 0.10  

No statistical analysis provided for Medial Diastolic Elastance



20.  Other Pre-specified:   Lateral Diastolic Elastance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Lateral Diastolic Elastance
Measure Description A decrease in Lateral Diastolic Elastance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  67     67  
Lateral Diastolic Elastance  
[units: (m/sec)/cc]
Mean ± Standard Deviation
  -0.00  ± 0.09     -0.01  ± 0.08  

No statistical analysis provided for Lateral Diastolic Elastance



21.  Other Pre-specified:   Medial Left Ventricular Relaxation   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Medial Left Ventricular Relaxation
Measure Description An increase in Left Ventricular relaxation is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  83     77  
Medial Left Ventricular Relaxation  
[units: m/sec]
Mean ± Standard Deviation
  0.00  ± 0.02     -0.00  ± 0.02  

No statistical analysis provided for Medial Left Ventricular Relaxation



22.  Other Pre-specified:   Lateral Left Ventricular Relaxation   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Lateral Left Ventricular Relaxation
Measure Description An increase in Left Ventricular relaxation is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  78     74  
Lateral Left Ventricular Relaxation  
[units: m/sec]
Mean ± Standard Deviation
  -0.00  ± 0.02     -0.00  ± 0.02  

No statistical analysis provided for Lateral Left Ventricular Relaxation



23.  Other Pre-specified:   Medial Filling Pressure   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Medial Filling Pressure
Measure Description A decrease in medial filling pressure is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  80     75  
Medial Filling Pressure  
[units: m/sec]
Mean ± Standard Deviation
  -1.64  ± 6.83     0.33  ± 6.04  

No statistical analysis provided for Medial Filling Pressure



24.  Other Pre-specified:   Lateral Filling Pressure   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Lateral Filling Pressure
Measure Description A decrease in lateral filling pressure is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  75     72  
Lateral Filling Pressure  
[units: m/sec]
Mean ± Standard Deviation
  -0.44  ± 5.17     -0.04  ± 5.68  

No statistical analysis provided for Lateral Filling Pressure



25.  Other Pre-specified:   ECHO Effective Arterial Elastance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title ECHO Effective Arterial Elastance
Measure Description A decrease in Effective Arterial Elastance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  76     68  
ECHO Effective Arterial Elastance  
[units: Farads-1]
Mean ± Standard Deviation
  0.03  ± 0.46     -0.07  ± 0.36  

No statistical analysis provided for ECHO Effective Arterial Elastance



26.  Other Pre-specified:   ECHO Systemic Vascular Resistance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title ECHO Systemic Vascular Resistance
Measure Description A decrease in Systemic Vascular Resistance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  74     66  
ECHO Systemic Vascular Resistance  
[units: Woods units]
Mean ± Standard Deviation
  0.01  ± 0.46     -0.01  ± 0.35  

No statistical analysis provided for ECHO Systemic Vascular Resistance



27.  Other Pre-specified:   MRI Effective Arterial Elastance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Effective Arterial Elastance
Measure Description A decrease in Effective Arterial Elastance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  45     47  
MRI Effective Arterial Elastance  
[units: Farads-1]
Mean ± Standard Deviation
  0.04  ± 0.44     -0.15  ± 0.38  

No statistical analysis provided for MRI Effective Arterial Elastance



28.  Other Pre-specified:   MRI Systemic Vascular Resistance   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Systemic Vascular Resistance
Measure Description A decrease in Systemic Vascular Resistance is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  45     47  
MRI Systemic Vascular Resistance  
[units: Woods units]
Mean ± Standard Deviation
  0.06  ± 0.57     -0.10  ± 0.39  

No statistical analysis provided for MRI Systemic Vascular Resistance



29.  Other Pre-specified:   MRI Aortic Thickness   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Aortic Thickness
Measure Description A decrease in Aortic Thickness is considered an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  33     31  
MRI Aortic Thickness  
[units: mm]
Mean ± Standard Deviation
  0.01  ± 0.17     -0.03  ± 0.18  

No statistical analysis provided for MRI Aortic Thickness



30.  Other Pre-specified:   MRI Aortic Distensibility   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title MRI Aortic Distensibility
Measure Description An increase in Aortic Distensibility is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  31     29  
MRI Aortic Distensibility  
[units: cm^2*dyne-1]
Mean ± Standard Deviation
  0.12  ± 0.66     0.29  ± 1.13  

No statistical analysis provided for MRI Aortic Distensibility



31.  Other Pre-specified:   ECHO Pulmonary Artery Systolic Pressure   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title ECHO Pulmonary Artery Systolic Pressure
Measure Description A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  58     45  
ECHO Pulmonary Artery Systolic Pressure  
[units: mmHg]
Mean ± Standard Deviation
  -0.15  ± 12.43     0.32  ± 10.09  

No statistical analysis provided for ECHO Pulmonary Artery Systolic Pressure



32.  Other Pre-specified:   Best Available Creatinine   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Best Available Creatinine
Measure Description Best available=local lab results only when core lab results not available
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  98     100  
Best Available Creatinine  
[units: mg/dL]
Mean ± Standard Deviation
  0.02  ± 0.23     0.09  ± 0.29  

No statistical analysis provided for Best Available Creatinine



33.  Other Pre-specified:   Best Available Glomerular Filtration Rate (GFR)   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Best Available Glomerular Filtration Rate (GFR)
Measure Description Best available=local lab results when core lab results not available
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  98     100  
Best Available Glomerular Filtration Rate (GFR)  
[units: mL/min/1.73m^2]
Mean ± Standard Deviation
  -0.91  ± 15.02     -3.27  ± 12.16  

No statistical analysis provided for Best Available Glomerular Filtration Rate (GFR)



34.  Other Pre-specified:   Cystatin C   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Cystatin C
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
Cystatin C  
[units: mg/L]
Mean ± Standard Deviation
  -0.01  ± 0.27     0.10  ± 0.29  

No statistical analysis provided for Cystatin C



35.  Other Pre-specified:   Uric Acid   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Uric Acid
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  94     94  
Uric Acid  
[units: mg/dL]
Mean ± Standard Deviation
  -0.11  ± 1.79     0.51  ± 1.80  

No statistical analysis provided for Uric Acid



36.  Other Pre-specified:   N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  94     95  
N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)  
[units: pg/mL]
Mean ± Standard Deviation
  -50.52  ± 799.87     158.25  ± 538.85  

No statistical analysis provided for N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)



37.  Other Pre-specified:   Aldosterone   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Aldosterone
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
Aldosterone  
[units: pg/mL]
Mean ± Standard Deviation
  7.04  ± 220.06     1.22  ± 213.47  

No statistical analysis provided for Aldosterone



38.  Other Pre-specified:   High Sensitivity Troponin I   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title High Sensitivity Troponin I
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     93  
High Sensitivity Troponin I  
[units: pg/mL]
Mean ± Standard Deviation
  3.88  ± 29.71     11.11  ± 62.49  

No statistical analysis provided for High Sensitivity Troponin I



39.  Other Pre-specified:   Procollagen III N-terminal Peptide   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Procollagen III N-terminal Peptide
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  93     95  
Procollagen III N-terminal Peptide  
[units: ug/L]
Mean ± Standard Deviation
  0.58  ± 5.22     0.41  ± 3.90  

No statistical analysis provided for Procollagen III N-terminal Peptide



40.  Other Pre-specified:   Endothelin-1   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Endothelin-1
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
Endothelin-1  
[units: pg/mL]
Mean ± Standard Deviation
  0.04  ± 1.51     0.49  ± 1.29  

No statistical analysis provided for Endothelin-1



41.  Other Pre-specified:   High Sensitivity C-Reactive Protein   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title High Sensitivity C-Reactive Protein
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
High Sensitivity C-Reactive Protein  
[units: mg/L]
Mean ± Standard Deviation
  0.36  ± 7.20     0.32  ± 5.49  

No statistical analysis provided for High Sensitivity C-Reactive Protein



42.  Other Pre-specified:   Collagen Type I (CITP)   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Collagen Type I (CITP)
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
Collagen Type I (CITP)  
[units: ug/L]
Mean ± Standard Deviation
  -0.17  ± 4.03     5.61  ± 48.96  

No statistical analysis provided for Collagen Type I (CITP)



43.  Other Pre-specified:   Cyclic Guanosine Monophosphate (cGMP)   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Cyclic Guanosine Monophosphate (cGMP)
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  95     95  
Cyclic Guanosine Monophosphate (cGMP)  
[units: pmol/mL]
Mean ± Standard Deviation
  1.28  ± 37.05     8.72  ± 30.22  

No statistical analysis provided for Cyclic Guanosine Monophosphate (cGMP)



44.  Other Pre-specified:   Galectin 3   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Galectin 3
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  93     92  
Galectin 3  
[units: ng/mL]
Mean ± Standard Deviation
  1.10  ± 9.63     1.26  ± 7.71  

No statistical analysis provided for Galectin 3



45.  Other Pre-specified:   Furosemide-Equivalent Dose   [ Time Frame: Change from Baseline to Week 24 ]

Measure Type Other Pre-specified
Measure Title Furosemide-Equivalent Dose
Measure Description No text entered.
Time Frame Change from Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Reporting Groups
  Description
Placebo placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Measured Values
    Placebo     Sildenafil  
Number of Participants Analyzed  
[units: participants]
  98     100  
Furosemide-Equivalent Dose  
[units: mg]
Mean ± Standard Deviation
  -0.23  ± 35.44     7.27  ± 59.53  

No statistical analysis provided for Furosemide-Equivalent Dose




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jenny Ibarra
Organization: Duke University
phone: 919.236.3291
e-mail: jenny.ibarra@duke.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00763867     History of Changes
Other Study ID Numbers: Pro00018007 (521), U01HL084904, U01 HL084904-01
Study First Received: September 30, 2008
Results First Received: April 4, 2013
Last Updated: July 2, 2013
Health Authority: United States: Federal Government