Spironolactone for Pulmonary Arterial Hypertension

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

DRUG

Spironolactone

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

DRUG

Placebo

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Pennsylvania

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• New England Medical Center, Tufts University School of Medicine

  collaborator UNKNOWN

• National Institutes of Health Clinical Center (CC)

  lead NIH

Principal Investigators

• Michael A Solomon, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-10

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations