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Mineralocorticoid Receptor Antagonist

Eplerenone for Primary Aldosteronism

Phase 4
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter and circumference of PET/CT scanner are 70 cm and 220 cm, respectively)
Hypertension treated with at least one antihypertensive drug
Must not have
History of MI, CABG, known cardiomyopathy (EF <40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation
Contraindication or allergy to eplerenone or spironolactone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions

Summary

This trial will study if a medication that blocks aldosterone can reduce heart & kidney disease risk for those with too much of the hormone.

Who is the study for?
This study is for adults aged 18-85 with high blood pressure treated with medication, specifically those diagnosed with Primary Aldosteronism (PA) who haven't been treated with drugs that block aldosterone. Participants must be able to fit in a PET/CT scanner and provide informed consent. People with a history of heart issues, allergy to eplerenone or spironolactone, current pregnancy, breastfeeding, or certain kidney problems cannot join.
What is being tested?
The trial is testing Eplerenone's effectiveness on heart function in individuals producing excess aldosterone. It aims to see if blocking aldosterone can improve cardiovascular health in PA patients. The study includes tests like cardiac PET scans and echocardiograms to monitor changes.
What are the potential side effects?
Eplerenone may cause side effects such as increased potassium levels which can affect the heart rhythm, dizziness, possibly leading to fainting spells; mild flu-like symptoms; diarrhea; abdominal pain; coughing; and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh less than 500 pounds and can fit into a PET/CT scanner.
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I am taking medication for high blood pressure.
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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart issues, including heart attack, heart surgery, weak heart muscle, or heart transplant.
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I am allergic or cannot take eplerenone or spironolactone.
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I am scheduled for adrenal gland surgery within the next 6 months.

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 myocardial flow reserve (MFR, unitless ratio)
Secondary study objectives
Change in Global Longitudinal Strain (%)
Change in LV Mass Index (g/m2 of body surface area)
Change in peak-stress myocardial blood flow (ml/min/g)

Side effects data

From 2012 Phase 4 trial • 1012 Patients • NCT01176968
5%
Chest pain
4%
Diarrhoea
4%
Hypotension
4%
Dizziness
3%
Angina pectoris
3%
Cough
3%
Abdominal pain upper
3%
Non-cardiac chest pain
2%
Dyspnoea
2%
Hypertension
2%
Bradycardia
2%
Anxiety
2%
Ventricular tachycardia
2%
Fatigue
2%
Oedema peripheral
2%
Diabetes mellitus
2%
Back pain
2%
Headache
1%
Pericarditis
1%
Constipation
1%
Nausea
1%
Cardiac failure
1%
Angina unstable
1%
Myocardial infarction
1%
Cerebrovascular accident
1%
Syncope
1%
Acute myocardial infarction
1%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eplerenone Plus Standard of Care
Placebo Plus Standard of Care

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Eplerenone TreatmentExperimental Treatment1 Intervention
Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eplerenone
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,195 Total Patients Enrolled

Media Library

Eplerenone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05030545 — Phase 4
High Blood Pressure Research Study Groups: Eplerenone Treatment
High Blood Pressure Clinical Trial 2023: Eplerenone Highlights & Side Effects. Trial Name: NCT05030545 — Phase 4
Eplerenone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030545 — Phase 4
~20 spots leftby Oct 2026
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