Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.

Detailed Description
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Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated. At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram. At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment. To achieve statistical significance, 64 patients will be enrolled and randomized.

Official Title
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Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Conditions
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Heart Failure With Reactive Pulmonary Hypertension

Intervention / Treatment
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* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated indication for right heart catheterization pulmonary artery mean pressure >25 mmHg pulmonary capillary wedge pressure > 15 mmHg pulmonary vascular resistance > 3 Wood units Exclusion Criteria: hypersensitivity, allergy, or intolerable side effect to sildenafil history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt co-morbidities, limited exercise intolerance: morbid obesity (BMI >40) COPD with oxygen dependence severe peripheral vascular disease with intermittent claudication status post amputation of lower extremity at any level severe degenerative joint disease preventing normal walking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo three times per day, orally | Drug: Placebo<br>* One capsule three times daily by mouth for 90 days<br>|
| Active Comparator: Sildenafil<br>Sildenafil 20 mg three times per day, orally | Drug: Sildenafil<br>* 20 mg three times daily by mouth for 90 days<br>* Other names: Viagra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Tolerance | In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment. | Baseline and 90 days |