At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 216 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX)
In Brief
A Phase 3 clinical trial evaluating Placebo and Sildenafil for Heart Failure. Completed, enrolled 216 participants across 10 sites in 2 countries.
Detailed Summary
Diastolic heart failure (DHF), which affects older individuals and women at a disproportionate rate, is a condition that can lead to shortness of breath and fluid build-up in the lungs. This study will evaluate the effectiveness of the medication sildenafil at improving exercise ability and health outcomes in people with DHF.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Pfizer
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedOct 2008
Primary CompletionSep 2012
TodayJul 2026
First PostedOct 1, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.8 years ago
Interventions
Placebodrug
Sildenafildrug