Status:
TERMINATED
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 an...
Detailed Description
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 randomi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02253394
Start Date
September 1 2015
End Date
February 1 2018
Last Update
November 15 2019
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115