Effects of Sildenafil on pulmonary artery pressure in patients with heart failure with preserved ejection fraction and pulmonary hypertension - Sildenafil in HFpEF and PH

Conditions: The condition to be investigated is isolated left heart failure , also called heart failure with preserved ejection fraction ( HFpEF) with pulmonary hypertension. HFpEF is a clinical syndrome with severe symptoms and high mortality. The presence of PH in HFpEF is associated with increased mortality . Nevertheless there is no evidence based medical treatment regiment for this condition.

Registration Number: EUCTR2010-020153-14-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 52

Inclusion Criteria

age>18 years
PAP >25 mmHg
wedge >15 mmHg
LVEF >45%
NZHA II/IV despite HF therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

exclusion criteria
severe noncardiac limitation to exercise
Other cause of PH besides HFpEF
Coronary ischemia or recent (6 months) myocardial infarction.
hypotension (90|50)
ongoing nitrate therapy
left sided valve dysfunction
severe liver dysfunction
pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective<br>To investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PH<br><br>;Secondary Objective: Secondary objectives<br>To investigate wether Sildenafil treatment results in a reduction of wedge pressure in HFpEF patients with PH.<br>To investigate wether Sildenafil treatment results in improvement of exercise capacity in these patients ( defined as change in VO2max ).;Primary end point(s): reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PH<br>

Secondary Outcome Measures