The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
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|ClinicalTrials.gov Identifier: NCT02253394|
Recruitment Status : Terminated (Low enrollment)
First Posted : October 1, 2014
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Ambrisentan plus Spironolactone Drug: Ambrisentan plus Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
Active Comparator: AMB + Spiro, Cardiopulmonary fitness
Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD
Drug: Ambrisentan plus Spironolactone
Other Name: Letairis plus Aldactone
Placebo Comparator: Placebo Cardiopulmonary fitness
Placebo mimics spironolactone 50 mg and will be taken QD
Drug: Ambrisentan plus Placebo
Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness
Other Name: Letairis
- Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output [ Time Frame: Up to average of 20 min ]Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253394
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Bradley Maron, MD||Brigham and Women's Hospital|