Status:
UNKNOWN
Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 spironola...
Detailed Description
Pulmonary arterial hypertension (PAH) is an orphan disease characterized by pulmonary artery hypertrophy, and resulting vascular remodeling of involved vessels, often leading to right heart failure. A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01468571
Start Date
July 1 2011
End Date
December 1 2015
Last Update
May 8 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030