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The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Ambrisentan plus Spironolactone (Drug); Ambrisentan plus Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Bradley Maron, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Overall contact:
Laurie Lawler, R.N., Phone: 617-525-9731, Email: llawler@partners.org

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.

Clinical Details

Official title: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver)

Primary outcome: Combination ambrisentan + spironolactone on cardiopulmonary fitness

Secondary outcome:

Effect of combination ambrisentan + spironolactone on cardiac output

Effect of combination ambrisentan + spironolactone on right ventricular function

Effect of combination ambrisentan + spironolactone on biochemical measures of heart failure.

Effect of combination ambrisentan + spironolactone on quality of life.

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 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.

Eligibility

Minimum age: 16 Years. Maximum age: 75 Years. Gender(s): Both.

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 one year of enrollment 3. Subject is 16-75 years of age 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

Locations and Contacts

Laurie Lawler, R.N., Phone: 617-525-9731, Email: llawler@partners.org

Brigham & Women's Hospital, Bosotn, Massachusetts 02115, United States; Not yet recruiting
Bradley Maron, MD, Principal Investigator

Boston Medical Center, Boston, Massachusetts 02118, United States; Not yet recruiting
Fei-Ying Cheong, PhD, MA, Phone: 617-638-4344, Email: fycheong@bu.edu
Harrison Farber, MD, Phone: (617) 638 4344, Email: hfarber@bu.edu

Tufts-New England Medical Center, Boston, Massachusetts 02111, United States; Not yet recruiting
Karen Visnaw, R.N, Phone: 617-636-1334, Email: kvisnaw@tufts-nemc.org
Nicholas Hill, MD, Phone: (617) 636-4288, Email: nhill@tufts-nemc.org

Additional Information

Starting date: January 2015
Last updated: September 27, 2014

Page last updated: August 23, 2015

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