Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure (PITCH-HF)

This study has been terminated.
(terminated by funding agency)
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT01910389
First received: July 25, 2013
Last updated: April 16, 2015
Last verified: January 2014
Results First Received: April 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Pulmonary Hypertension
Interventions: Drug: Tadalafil
Drug: Placebo for tadalafil

  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
Tadalafil Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
Placebo Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.

Participant Flow:   Overall Study
    Tadalafil     Placebo  
STARTED     15     8  
COMPLETED     0     0  
NOT COMPLETED     15     8  
Withdrawal by Subject                 2                 0  
Study Closed                 13                 8  



  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
Tadalafil Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
Placebo Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
Total Total of all reporting groups

Baseline Measures
    Tadalafil     Placebo     Total  
Number of Participants  
[units: participants]
  15     8     23  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     4     14  
>=65 years     5     4     9  
Age  
[units: years]
Median (Inter-Quartile Range)
  62.6   (42.3 to 72.5)     63.3   (51.7 to 76.8)     62.6   (47.7 to 73.9)  
Gender  
[units: participants]
     
Female     2     1     3  
Male     13     7     20  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     14     8     22  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     11     6     17  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  



  Outcome Measures
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1.  Primary:   Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

2.  Secondary:   Cardiovascular Mortality   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

3.  Secondary:   Heart Failure Hospitalization   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

4.  Secondary:   All-cause Mortality   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

5.  Secondary:   Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

6.  Secondary:   Frequency of CV Hospitalizations   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

7.  Secondary:   Frequency of HF Hospitalizations   [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]

8.  Secondary:   Change in 6 Minute Walk Distance From Baseline to 3 Months   [ Time Frame: Randomization to 3 months ]

9.  Secondary:   Change in MLHFQ Score From Baseline to 3 Months   [ Time Frame: Randomization to 3 months ]

10.  Secondary:   Change in 6 Minute Walk Distance From Baseline to 18 Months   [ Time Frame: Randomization to 18 months ]

11.  Secondary:   Trend in 6 Minute Walk Distance From Baseline Through 18 Months   [ Time Frame: Randomization to 18 months ]

12.  Secondary:   Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months   [ Time Frame: Randomization to 18 months ]

13.  Secondary:   Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months   [ Time Frame: Randomization to 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination leading to small numbers of subjects. Outcome measure data not obtained.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brian Harty
Organization: New England Research Institutes
phone: 617-972-3224
e-mail: bhartY@neriscience.com


No publications provided


Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT01910389     History of Changes
Other Study ID Numbers: U01HL105463
Study First Received: July 25, 2013
Results First Received: April 16, 2015
Last Updated: April 16, 2015
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board