Pulmonary Hypertension | Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension
Pulmonary Hypertension research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Spironolactone50 mg po daily of spironolactone for 8 weeks. A cross-over study where each subject will receive spironolactone or placebo in a random order for 8 weeks each.
Drug:PlaceboEach subject will receive placebo or spironolactone for 8 weeks. At the end of week 8, treatment arm for each subject will be blindly switched. So if a study patient received placebo for the first 8 weeks then he/she will be switched to receive active drug (spironolactone) for the next 8 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SpironolactoneDrug: Spironolactone Drug: Placebo
PlaceboDrug: Placebo Drug: Spironolactone
Start Date: July 2011
Completed Date: December 2015
Phase: Phase 4
Primary Outcome: Change in biomarker levels in the spironolactone treated as compared to placebo treated group.
Secondary Outcome: Number of adverse events in patients treated with spironolactone as compared to placebo.
Study sponsors, principal investigator, and references
Principal Investigator: Zeenat Safdar, MD
Lead Sponsor: Baylor College of Medicine
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)