Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. In addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Age 18 years or older

• Body weight > 40 kg

• PAH Diagnostic Group I

• Stable subjects with no change in PAH specific therapy within the last 4 weeks

• No change in dose of background therapy (digoxin, diuretic) within the last 2 weeks excluding anticoagulation

Exclusion Criteria:

• Unable to give informed consent

• Hemodynamically unstable subjects

• Pregnant or breast feeding

• Have significant renal insufficiency (serum creatinine >2.5 mg per deciliter or required hemodialysis)

• Have significant liver dysfunction (AST or ALT more than three times upper limit of normal)

• Currently on aldosterone receptor blocker (spironolactone or eplerenone) or ACE inhibitor

• PH due to left heart disease

• Unable or unwilling to comply with study procedures