Spironolactone for Pulmonary Arterial Hypertension
Eligible age
18–100 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to worsening of the disease. A drug called spironolactone has been known to improve blood vessel function and reduce inflammation. Some people with PAH take spironolactone to help treat fluid retention. However, its effect on inflammation and blood vessel function in patients with PAH is not known. Researchers want to see if spironolactone can help these conditions in people with PAH. Objectives: \- To test the effectiveness of spironolactone in treating pulmonary arterial hypertension. Eligibility: \- Individuals at least 18 years of age with pulmonary arterial hypertension. Design: * This study will last for 24 weeks. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will take either spironolactone or a placebo. They will take their study drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests. * In Week 8, participants who have had no reaction to the treatment will receive a higher dose of the drug or placebo. * In Week 12, participants will have a study visit with heart and lung function tests. They will also have a 6-minute walk test, and provide blood and urine samples. * After additional study visits for blood samples, participants will have a final visit in Week 24. The tests from Week 12 will be repeated at this visit.
Sponsor: National Institutes of Health Clinical Center (CC)
You may not qualify if…
- ✕ 1. Patients with WHO Group 1 PH and evidence of right heart failure as defined by:
- ✕ 1. NYHA/WHO class IV symptoms and
- ✕ 2. Echocardiographic evidence of severe RV dysfunction and
- ✕ 3. Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, and lower extremity edema
- ✕ 2. Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites, hepatic encephalopathy and/or varices prior to enrollment
- ✕ 3. Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of \< 500 on their most recent determinations within the past 12 months will be considered to have inactive infection)
- ✕ 4. Patients with WHO Group 1 pulmonary hypertension who have taken spironolactone or eplerenone within the last 30 days
- ✕ 5. Known or suspected allergy to spironolactone
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT01712620 · last updated 2026-06-09