Pulmonary Arterial Hypertension Clinical Trial
Official title:
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.
A prospective, double blind, placebo-controlled clinical study involving 30 patients with
World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with
ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a
cross-over trial design.
Eligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for
90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point
assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the
trial will occur (Phase II), in which participants randomized to placebo in Phase I will be
treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase
II, end-point measures are reassessed.
Spironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually
added to medical treatment when doses of Lasix/Torsemide are increased and patients are at
risk for hypokalemia.
Study procedures being done for this research study are the standard procedures performed on
all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary
Exercise Test (CPET) with Innocor.
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