Spironolactone for Pulmonary Arterial Hypertension
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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 withPAH 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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborators:
Medstar Health Research Institute National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) New England Medical Center, Tufts University School of Medicine University of Maryland University of Maryland, College Park University of Pennsylvania Washington Hospital Center