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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT01468571

Run by

Baylor College of Medicine

People needed

50

Starts

2011-07-01

Expected to finish

2015-12-01

Last updated by the study team

2015-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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