Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01726049|
Recruitment Status : Completed
First Posted : November 14, 2012
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Diastolic Pulmonary Hypertension||Drug: Sildenafil Drug: Placebo||Phase 3|
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:
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) .
- To investigate whether Sildenafil treatment results in an reduction of wedge pressure in HFpEF patients.
- To investigate whether Sildenafil treatment results in an improvenemt of cardiac output (CO) in HFpEF patients.
- To investigate whether Sildenafil treatment results in improvement of exercise capacity in these patients ( defined as change in VO2max)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Sildenafil on Pulmonary Arterial Pressure in Patients With Heart Failure With Preserved Ejection Fraction ( HFpEF) and Pulmonary Hypertension|
|Study Start Date :||October 2011|
|Primary Completion Date :||September 2014|
|Study Completion Date :||December 2014|
Active Comparator: Sildenafil
Sildenafil orally 3 times 20mg for 2 weeks , followed by 3 times 60 mg for 10 weeks
Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
Placebo Comparator: Placebo
placebo orally 3 times 20mg tablets, followed by 3 times 60 mg for 10 weeks
Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
- Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization [ Time Frame: baseline and 12 weeks ]change of mean pulmonary artery pressure between baseline and 12 weeks measured by heart catheterisation
- VO2max [ Time Frame: baseline and 12 weeks ]difference in change of VO2 max between baseline and 12 weeks between Sildenafil and placebo group
- Cardiac Output Measured Invasively by Right Heart Catheterization [ Time Frame: baseline and 12 weeks ]difference in change of cardiac output between baseline and 12 weeks between Sildenafil and Placebo group
- Wedge Pressure Measured Invasively by Right Heart Catheterization [ Time Frame: baseline and 12 weeks ]Difference in change of wedge pressure between baseline and 12 weeks between Sildenafil group and Placebo group
- Echocardiographic Parameters of Diastolic LV Dysfunction [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726049
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Principal Investigator:||E S Hoendermis, MD PhD||University Medical Center Groningen|