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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I weigh less than 500 pounds and can fit into a PET/CT scanner.
Select...
I am taking medication for high blood pressure.
Select...
I am between 18 and 85 years old.
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 myocardial flow reserve (MFR, unitless ratio)
Secondary outcome measures
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 • NCT011769685%
Chest pain
4%
Diarrhoea
4%
Hypotension
4%
Dizziness
3%
Angina pectoris
3%
Abdominal pain upper
3%
Cough
3%
Non-cardiac chest pain
2%
Anxiety
2%
Bradycardia
2%
Ventricular tachycardia
2%
Dyspnoea
2%
Hypertension
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
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
1,626 Previous Clinical Trials
11,472,717 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart issues, including heart attack, heart surgery, weak heart muscle, or heart transplant.I am allergic or cannot take eplerenone or spironolactone.I am scheduled for adrenal gland surgery within the next 6 months.I am scheduled for a heart vessel examination or treatment within the next 6 months.I weigh less than 500 pounds and can fit into a PET/CT scanner.I've had a heart PET scan and an echocardiogram recently.I am taking medication for high blood pressure.I am between 18 and 85 years old.Your kidney function (eGFR) is very low or your potassium levels are very high based on recent lab tests.I have primary aldosteronism and haven't been treated with mineralocorticoid receptor antagonists.Cohort B: PET scan shows 10% or more of the heart has reduced blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: Eplerenone Treatment
Awards:
This trial has 5 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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