Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Pfizer
• Treatments: Sildenafil Citrate

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