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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020153-14-NL

Enrollment

Registered

2011-01-11

Start date

2011-01-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Revatio Product Name: Revatio Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective To investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PH ;Secondary Objective: Secondary objectives To investigate wether Sildenafil treatment results in a reduction of wedge pressure in HFpEF patients with PH. 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	—

Measure

Time frame

Main Objective: Primary objective To investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PH ;Secondary Objective: Secondary objectives To investigate wether Sildenafil treatment results in a reduction of wedge pressure in HFpEF patients with PH. 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

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026