Phase 3
N=52
Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH
Heart Failure, Diastolic · Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01726049 ↗Enrolled (actual)
52
Serious AEs
13.5%
Results posted
Mar 2016
Primary outcome: Primary: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization — -2.4; -4.7 mmHG
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sildenafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center Groningen
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization |
-2.4; -4.7 | — |
| SECONDARY VO2max |
0.2; 0.7 | — |
| SECONDARY Cardiac Output Measured Invasively by Right Heart Catheterization |
-0.4; -0.2 | — |
| SECONDARY Wedge Pressure Measured Invasively by Right Heart Catheterization |
-0.5; -3.5 | — |
Summary
Aim of the study is to investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF) with pulmonary hypertension ( PH).
Eligibility Criteria
Inclusion Criteria
- >18 years
- Written inform consent
- PH secondary to diastolic left heart failure defined as
- PAP mean >25 mmHg
- Wedge mean >15 mmHg
- Normal systolic left ventricular (LV) function on echo/nuclear imaging (left ventricular ejection fraction (LVEF) > or =45%)
- New York Heart Association class (NYHA) II-IV despite heart failure therapy
Exclusion Criteria
- Severe noncardiac limitation to exercise (as severe chronic obstructive pulmonary disease)
- Other cause of PH besides diastolic heart failure
- Coronary ischemia or recent myocardial infarction (<6 months)
- Hypotension ( <90/50 mmHg)
- Ongoing nitrate therapy
- Ongoing therapy with citochrome P450 3A4 ( CYP3A4) inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or CYP3A4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, Sint Janskruid ). Furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of Sildenafil.
- Ongoing therapy with alpha -inhibitors
- Significant mitral or aortic valve dysfunction
- Severe liver dysfunction
- Pregnancy
- Unable to read and comprehend Dutch language
Data sourced from ClinicalTrials.gov (NCT01726049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.