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

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ClinicalTrials.gov Identifier: NCT00763867
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : July 3, 2013
Last Update Posted : July 23, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Drug: Placebo
Drug: Sildenafil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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


  Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information