Heart Failure With Reactive Pulmonary Hypertension Clinical Trial
Official title:
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
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.
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.
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