Overview

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Status:
Terminated
Trial end date:
2018-02-01
Target enrollment:
0
Participant gender:
All
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 and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborator:
Gilead Sciences
Treatments:
Ambrisentan
Spironolactone
Criteria
Inclusion Criteria:

1. Voluntarily gives informed consent to participate in the study.

2. 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

3. Subject is 18 years of age or older at Screening.

4. 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.

5. New York Heart Association Functional Class II or III

6. Stable therapy with ambrisentan 5 or 10 mg every day for > 90 days.

7. Baseline 6-Minute Walk Distance 50-450m

Exclusion Criteria:

1. 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

2. Left ventricular ejection fraction < 50%

3. Pulmonary capillary wedge pressure > 16 mm Hg

4. Aortic valve disease

5. Ischemic heart disease

6. Systemic hypotension (SBP <90 mm Hg)

7. Co-existing treatment with other endothelin receptor antagonists or prostacyclin
analogues

8. New York Heart Association Functional Class IV

9. Chronic thromboembolic pulmonary hypertension

10. Known or suspected pulmonary veno-occlusive disease

11. Serum creatinine >2.0 mg/dL in women, Serum creatinine >2.5 mg/dL in men

12. Baseline serum potassium >5.0 milliequivalent (mEq)/L

13. Participation in ongoing drug/intervention-based clinical trial

14. Pregnancy

15. Unable to provide consent