Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | January 2015 |
| End Date: | June 2017 |
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.
effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a
double-blind, placebo controlled trial.
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.
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.
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
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