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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in placebo corrected 6-minute walk distance
Secondary outcome measures
Biomarkers of vascular inflammation
Change in placebo corrected VO2 max
Change in right ventricular function
+1 moreSide effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Diabetes related
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
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
~7340
Find a Location
Who is running the clinical trial?
Medstar Health Research InstituteOTHER
191 Previous Clinical Trials
117,571 Total Patients Enrolled
University of PennsylvaniaOTHER
2,012 Previous Clinical Trials
42,897,139 Total Patients Enrolled
6 Trials studying Pulmonary Arterial Hypertension
186 Patients Enrolled for Pulmonary Arterial Hypertension
New England Medical Center, Tufts University School of MedicineUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to spironolactone.I am taking both an ACE inhibitor and an angiotensin II blocker.I am under 18 years old.I have WHO Group 1 pulmonary hypertension and have been on stable or no treatment for the last 4 weeks.I have severe pulmonary hypertension with signs of right heart failure.I have WHO Group 1 pulmonary hypertension and have taken spironolactone or eplerenone recently.I am unable to sign the consent form for this study.I have chronic kidney disease.I have had a severe allergic reaction to gadolinium or have chronic kidney disease.I am on the highest dose of ACE inhibitor or angiotensin II blocker.I do not have any implants or conditions that prevent me from having an MRI.I have high blood pressure in the lungs due to liver cirrhosis.I have high blood pressure in the lungs and an active infection.Your blood potassium level is higher than 5 mEq/L when you join the study.I am currently using birth control pills that contain drospirenone.Your heart and lung tests must show specific pressures that indicate a certain type of heart and lung condition.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have any openings for participants?
"Affirmative. Clinicaltrials.gov's entries verify that this experiment is actively looking for contributors, with its first post being on the 10th of January 2014 and most recent edit occurring on the 9th of November 2022. 70 volunteers are needed from two distinct medical centres."
Answered by AI
Has there been further research conducted on Spironolactone?
"Currently, 28 Spironolactone trials are underway with 7 of them in the final phase. At least 293 sites across the country have clinical studies related to this drug and a number of these can be found in Boston, Massachusetts."
Answered by AI
What is the sample size of this research project?
"Afirmative. The clinical trials website indicates that the study is currently recruiting participants, which began on January 10th 2014 and was last updated November 9th 2022. A total of 70 patients must be sourced from two sites for this trial to succeed."
Answered by AI
How perilous is the use of Spironolactone for people?
"The safety score of Spironolactone was assessed as a 2 due to it being in Phase 2 with clinical data suggesting its security, yet not conclusively proven for efficacy."
Answered by AI
In what medical conditions is Spironolactone commonly prescribed?
"Spironolactone can be utilized to address primary hyperaldosteronism, cirrhosis of the liver, and as an adjunct therapeutic procedure."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
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