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Mineralocorticoid Receptor Antagonist

Spironolactone for Pulmonary Arterial Hypertension

Phase 2
Recruiting
Led By Michael A Solomon, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Concurrent use of an ACE inhibitor and angiotensin II receptor blocker
Age <18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing whether spironolactone can help treat pulmonary arterial hypertension by looking at its effects on inflammation and blood vessel function.

Who is the study for?
Adults with pulmonary arterial hypertension (PAH) who are either not on treatment or have been stable on current therapy for at least 4 weeks. Participants must meet specific criteria related to heart and lung pressure measurements, and women of childbearing age must use contraception. Excluded are those with severe right heart failure, infections, high potassium levels, certain medication uses, kidney disease, under 18 years old, recent spironolactone users, allergies to it, or pregnant/breastfeeding women.
What is being tested?
The trial is testing if spironolactone can improve the condition of patients with PAH by reducing inflammation and improving blood vessel function. Over a period of 24 weeks, participants will receive either spironolactone or a placebo while undergoing regular monitoring through physical exams as well as heart and lung function tests.
What are the potential side effects?
Spironolactone may cause side effects such as electrolyte imbalances (like high potassium), breast enlargement in men (gynecomastia), menstrual irregularities in women, gastrointestinal issues like nausea or vomiting; dizziness; rash; headache; fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking both an ACE inhibitor and an angiotensin II blocker.
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I am under 18 years old.
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I have severe pulmonary hypertension with signs of right heart failure.
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I am unable to sign the consent form for this study.
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I have chronic kidney disease.
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I have had a severe allergic reaction to gadolinium or have chronic kidney disease.
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I am on the highest dose of ACE inhibitor or angiotensin II blocker.
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I have high blood pressure in the lungs due to liver cirrhosis.
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I have high blood pressure in the lungs and an active infection.
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I am currently using birth control pills that contain drospirenone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in placebo corrected 6-minute walk distance

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Hyperkalemia
5%
Infection
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group AExperimental Treatment1 Intervention
Spironolactone
Group II: Group BPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~14570

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteOTHER
197 Previous Clinical Trials
186,001 Total Patients Enrolled
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,978 Total Patients Enrolled
7 Trials studying Pulmonary Arterial Hypertension
206 Patients Enrolled for Pulmonary Arterial Hypertension
New England Medical Center, Tufts University School of MedicineUNKNOWN
University of Maryland Medical CenterUNKNOWN
2 Previous Clinical Trials
464 Total Patients Enrolled
National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,879,666 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
297 Patients Enrolled for Pulmonary Arterial Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,863 Total Patients Enrolled
27 Trials studying Pulmonary Arterial Hypertension
3,161 Patients Enrolled for Pulmonary Arterial Hypertension
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,333 Total Patients Enrolled
Michael A Solomon, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
4 Previous Clinical Trials
1,485 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
297 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Spironolactone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT01712620 — Phase 2
Pulmonary Arterial Hypertension Research Study Groups: Group A, Group B
Pulmonary Arterial Hypertension Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT01712620 — Phase 2
Spironolactone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01712620 — Phase 2
~11 spots leftby Dec 2026
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