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Eplerenone for Heart Disease Detection in Diabetes

Phase 1
Waitlist Available
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
Concomitant cytochrome P450 (CYP3A4) inhibitors or inducers;
Concomitant potassium supplementation or potassium sparing diuretics;
Must not have
History of prior MI or coronary revascularization (by Q waves on electrocardiogram in 2 contiguous leads or by clinical history)
Clinical HF (with prior hospital admission for HF or documentation of reduced LV ejection fraction after index CMR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is looking at whether a non-invasive test, cardiac MRI, can help predict which people with diabetes are at risk for heart disease.

Who is the study for?
This trial is for people over 40 with Type 2 Diabetes who have a higher risk of heart disease but haven't had a heart attack or severe non-cardiac illnesses. They should not be pregnant, have kidney issues, or take certain other medications that could interfere with the study drugs.
What is being tested?
The trial tests if Eplerenone can prevent heart problems by looking at 'diffuse scar tissue' in the heart using cardiac MRI. Participants will either receive Eplerenone or a placebo and will be monitored for five years to see how effective the treatment is.
What are the potential side effects?
Eplerenone may cause high potassium levels, which can affect your heartbeat, make you feel tired or weak, cause numbness or tingling, slow down your breathing rate, or increase your chances of getting dehydrated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not taking any drugs that affect liver enzyme CYP3A4.
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I am taking potassium supplements or diuretics that save potassium.
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I am 40 years old or older.
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I have type II diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack or surgery to improve blood flow to my heart.
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I have heart failure, confirmed by hospital admission or tests showing reduced heart function.
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I do not have a severe illness like advanced liver disease, cancer, or HIV/AIDS.
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I am taking potassium supplements or diuretics that save potassium.
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I am taking both ACE inhibitors and ARB medications.
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My kidney function is low, with GFR under 50 or creatinine over 1.5.
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I am not taking drugs that affect liver enzyme CYP3A4.
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I do not have a reliable phone number for contact.
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I have or might have a heart condition like myocarditis or sarcoid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 4 trial • 1012 Patients • NCT01176968
5%
Chest pain
4%
Diarrhoea
4%
Hypotension
4%
Dizziness
3%
Angina pectoris
3%
Abdominal pain upper
3%
Cough
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%
Nausea
1%
Constipation
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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EplerenoneExperimental Treatment1 Intervention
In a subgroup of 50 patients, 25 will be randomized to eplerenone to assess effects on fibrotic index pre- and post-6 months of therapy.
Group II: Sugar pillPlacebo Group1 Intervention
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
11,876,232 Total Patients Enrolled

Media Library

Eplerenone Clinical Trial Eligibility Overview. Trial Name: NCT01794091 — Phase 1
Type 2 Diabetes Research Study Groups: Eplerenone, Sugar pill
Type 2 Diabetes Clinical Trial 2023: Eplerenone Highlights & Side Effects. Trial Name: NCT01794091 — Phase 1
Eplerenone 2023 Treatment Timeline for Medical Study. Trial Name: NCT01794091 — Phase 1
~4 spots leftby Dec 2025
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