The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT02253394

Run by

Brigham and Women's Hospital

People needed

2

Starts

2015-09-01

Expected to finish

2018-02-01

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily gives informed consent to participate in the study.
• Right heart catheterization demonstrating conventional mean pulmonary artery pressure (mPAP) >25, pulmonary vascular resistance (PVR) >3.0 Wood Units, pulmonary capillary wedge pressure (PCWP) <16 mmHg within two years of enrollment
• Subject is 18 years of age or older at Screening.
• Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV infection.
• New York Heart Association Functional Class II or III
• Stable therapy with ambrisentan 5 or 10 mg every day for > 90 days.
• Baseline 6-Minute Walk Distance 50-450m

You may not qualify if…

• Substantial Primary Lung disease
• forced expiratory volume at one second (FEV-1)/forced vital capacity (FVC) <0.6 and FEV-1 <70% predicted
• diffusing capacity of lung for carbon monoxide (DLCO) <30% predicted
• Pulmonary fibrosis
• Left ventricular ejection fraction < 50%
• Pulmonary capillary wedge pressure > 16 mm Hg
• Aortic valve disease
• Ischemic heart disease
• Systemic hypotension (SBP <90 mm Hg)
• Co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues
• New York Heart Association Functional Class IV
• Chronic thromboembolic pulmonary hypertension
• Known or suspected pulmonary veno-occlusive disease
• Serum creatinine >2.0 mg/dL in women, Serum creatinine >2.5 mg/dL in men
• Baseline serum potassium >5.0 milliequivalent (mEq)/L
• Participation in ongoing drug/intervention-based clinical trial
• Pregnancy
• Unable to provide consent

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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