RecruitingPhase 2NCT01712620

Spironolactone for Pulmonary Arterial Hypertension

A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension


Sponsor

National Institutes of Health Clinical Center (CC)

Enrollment

70 participants

Start Date

Jan 10, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether spironolactone, a blood pressure medicine, can help people with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the lungs is dangerously high — by reducing strain on the heart. **You may be eligible if...** - You have been diagnosed with Group 1 pulmonary arterial hypertension confirmed by a heart catheter test - Your treatment has been stable for at least the past 4 weeks - You are 18 or older **You may NOT be eligible if...** - You are in the most severe stage of PAH with signs of right-sided heart failure (severe swelling, fluid buildup, severely abnormal heart function on echocardiogram) - You have cirrhosis of the liver with a history of fluid in the abdomen, confusion from liver disease, or enlarged veins in the esophagus - You have an active uncontrolled infection (controlled HIV may be okay) - You have taken spironolactone or eplerenone in the past 30 days - You are allergic to spironolactone - You are pregnant or breastfeeding - You have significant kidney disease - You have high potassium levels in your blood - You are on certain combinations of blood pressure medications - You take a birth control pill containing drospirenone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpironolactone

Initial dose, 25 mg (pink capsule) orally, daily. If well tolerated at 7-9 wks then increased to 50 mg (brown capsule) daily.

DRUGPlacebo

Initial dose, pink sugar capsule, daily. If well tolerated at 7-9 wks then changed to brown sugar capsule, daily.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01712620


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