Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	Sildenafil 20 mg three times per day, orally
Placebo	Placebo	Placebo three times per day, orally

Primary Outcome Measures

Name	Time	Method
Change in Exercise Tolerance	Baseline and 90 days	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.

Secondary Outcome Measures