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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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am 40 years old or older.
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I have type II diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All cause mortality, cardiovascular death, myocardial infarction or stroke
Side effects data
From 2012 Phase 4 trial • 1012 Patients • NCT011769685%
Chest pain
4%
Diarrhoea
4%
Hypotension
4%
Dizziness
3%
Abdominal pain upper
3%
Angina pectoris
3%
Cough
3%
Non-cardiac chest pain
2%
Hypertension
2%
Anxiety
2%
Bradycardia
2%
Ventricular tachycardia
2%
Dyspnoea
2%
Fatigue
2%
Oedema peripheral
2%
Diabetes mellitus
2%
Back pain
2%
Headache
1%
Constipation
1%
Nausea
1%
Pericarditis
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
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
1,608 Previous Clinical Trials
11,469,827 Total Patients Enrolled
30 Trials studying Diabetes
1,977,932 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood potassium level is higher than 5.0 mEq/L before starting the treatment.You have a condition called microalbuminuria in your urine.I have had a heart attack or surgery to improve blood flow to my heart.I have heart failure, confirmed by hospital admission or tests showing reduced heart function.I am over 75 years old.My blood's hematocrit level was below 30% within the last year, or I've had active bleeding in the past 3 months.My kidney function is low, with a GFR less than 45.I do not have a severe illness like advanced liver disease, cancer, or HIV/AIDS.I am taking potassium supplements or diuretics that save potassium.I am taking both ACE inhibitors and ARB medications.My kidney function is low, with GFR under 50 or creatinine over 1.5.I have or might have a heart condition like myocarditis or sarcoid.I am taking potassium supplements or diuretics that save potassium.I am not taking drugs that affect liver enzyme CYP3A4.Your blood pressure is consistently higher than 140 mmHg on two different occasions.I do not have a reliable phone number for contact.I am not taking any drugs that affect liver enzyme CYP3A4.You need to have a specific type of stress test that shows you have a low risk of heart problems.I am 40 years old or older.You have metal inside your body that could cause harm during the study.Your risk score for developing diabetes-related complications over the next 10 years is higher than 15%.I have type II diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Eplerenone
- Group 2: Sugar pill
Awards:
This trial has 2 awards, including:- 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.
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 particular experiment include individuals aged 55 and beyond?
"People aged 40 and above but below 75 are eligible for enrollment in this clinical trial."
Answered by AI
Is enrollment for this research study still available?
"According to the information on clinicaltrials.gov, this medical trial is not currently accepting patients as it was last updated on February 15th 2013. Nonetheless, there are 800 other active studies actively enrolling volunteers at the moment."
Answered by AI
What is the typical purpose of taking Eplerenone medication?
"Eplerenone is a suitable medication for those with Left Ventricular Ejection Fraction (LVEF) below 40%, congestive heart failure, hypertensive disorder and hypesthesia."
Answered by AI
How has the safety of Eplerenone been assessed in recent studies?
"Since this is an experimental Phase 1 trial, the safety of Eplerenone was rated a 1 due to the limited evidence on its efficacy and adverse effects."
Answered by AI
What is the aggregate sample size for this clinical trial?
"This clinical trial has concluded its patient recruitment. It was initially posted on August 1, 2013 and last updated February 15th of the same year. If seeking other trials, there are 787 studies with active recruitment for diabetes mellitus type 2 and 13 research projects with an open call for patients to test Eplerenone."
Answered by AI
Is it possible for me to partake in this medical study?
"For Phase I of this prospective cohort study, the research team seeks 50 participants between the ages of 40 and 75 who have type 2 diabetes mellitus. Additionally, these patients need to possess a UKPDS 10 year Risk Score higher than 15%, as well as pass a low-risk stress test which is explicitly outlined in our protocol."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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