Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH
NCT01726049
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- >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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH | |||
Official Title ICMJE | Effects of Sildenafil on Pulmonary Arterial Pressure in Patients With Heart Failure With Preserved Ejection Fraction ( HFpEF) and Pulmonary Hypertension | |||
Brief 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). | |||
Detailed Description | Rationale: Treatment of diastolic left heart failure is a challenging task. Compared to systolic left heart failure the level of evidence for known medical treatment regiments is low. Sildenafil, a phosphodiesterase 5 (PDE 5) inhibitor and effective therapy for pulmonary arterial hypertension acts as a selective pulmonary vasodilator by inhibiting the impaired nitric oxide (NO) pathway. Reducing the pulmonary vascular resistance would be the primary target by treatment of diastolic left heart failure with PH. But clinical and hemodynamical studies to evaluate the role of Sildenafil in diastolic heart failure, also called heart failure with preserved ejection fraction (HFpEF) with secondary pulmonary hypertension are lacking. Our hypothesis is that Sildenafil decreases pulmonary artery pressure in patients with HFpEF and pulmonary hypertension. Objective: To investigate whether Sildenafil treatment results in a hemodynamic improvement and in an improvement of exercise capacity in these patients. Study design: single-center, prospective, randomized, placebo controlled study. Study population: 52 patients with HFpEF and PH Intervention : One group receives three times daily 20 mg Sildenafil for 2 weeks followed by three times daily 60 mg Sildenafil for 10 weeks. The other group receives three times daily 20 mg of Placebo, followed by 3 times daily 60 mg placebo. Main study parameters/endpoints: Primary objectives 1. To investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure (PAP) in HFpEF patients with PH (investigated invasively by right heart catheterization) . Secondary objectives
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 52 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01726049 | |||
Other Study ID Numbers ICMJE | Sildenafil Groningen Study | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | E.S. Hoendermis, University Medical Center Groningen | |||
Study Sponsor ICMJE | University Medical Center Groningen | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University Medical Center Groningen | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |