Your session is about to expire
← Back to Search
Mineralocorticoid Receptor Antagonist
Eplerenone for High Blood Pressure
Phase 4
Recruiting
Led By Gail K Adler, MD, PhD
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
For men: LV mass index > 134 g/m2
For women: LV mass index > 110 g/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial will study how a mineralocorticoid receptor antagonist affects heart structure and function in people with high BP and LVH.
Who is the study for?
This trial is for men and women with high blood pressure and left ventricular hypertrophy (LVH), which means their heart's pumping chamber has thickened walls. Participants should have a history of hypertension but not severe illnesses like uncontrolled diabetes, serious heart failure, or recent major cardiovascular events. They must be between 18 to 70 years old and cannot be on certain medications like MR antagonists recently.Check my eligibility
What is being tested?
The study tests if Eplerenone (a drug blocking certain hormone receptors) is better than Chlorthalidone (a diuretic) at improving heart vessel function and efficiency in people with LVH due to high blood pressure. It's a randomized controlled trial where participants are assigned by chance to one of the treatments.See study design
What are the potential side effects?
Possible side effects include changes in potassium levels that can affect the heart rhythm, kidney function issues, dehydration from increased urination with Chlorthalidone, and potential hormonal imbalances with Eplerenone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's muscle mass is above the normal range.
Select...
My heart's left ventricle mass index is over 110 g/m2.
Select...
My blood pressure is below 180/110 mmHg while on medication.
Select...
My blood pressure is high but I'm not on blood pressure medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 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
Secondary outcome measures
Change in myocardial external efficiency
Trial Design
2Treatment groups
Active Control
Group I: EplerenoneActive Control1 Intervention
Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 50 mg eplerenone . At 2 weeks, eplerenone will be increased to 100 mg. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of <135/85 mmHg.
Group II: Chlorthalidone + potassiumActive Control2 Interventions
Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of <135/85 mmHg.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,873 Total Patients Enrolled
Gail K Adler, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
6 Previous Clinical Trials
218 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of high blood pressure.I have had high blood pressure caused by another condition.My heart's muscle mass is above the normal range.Your blood tests show abnormal levels of electrolytes, liver enzymes, or thyroid hormone.My heart's left ventricle mass index is over 110 g/m2.I experience significant drops in blood pressure when standing up.I have not had a heart attack, stroke, or major heart procedure in the last 6 months.I have used a medication like eplerenone or spironolactone in the past year.I have a liver condition.I have severe heart failure or unstable chest pain.Your heart's pumping function is less than 40%.My diabetes is under control (HbA1c ≤ 7.5).I have managed hypothyroidism or diabetes/pre-diabetes with diet, exercise, or metformin.I have a genetic heart muscle disorder.My kidney function is normal, with creatinine levels below 1.5 mg/dL for men and 1.3 mg/dL for women.I am on hormone replacement therapy.My blood pressure is below 180/110 mmHg while on medication.My blood pressure is high but I'm not on blood pressure medication.I am between 18 and 70 years old.I have a lung condition that causes my airways to narrow.Your heart is abnormally large according to an echocardiogram.You have problems with alcohol or using drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Eplerenone
- Group 2: Chlorthalidone + potassium
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Has Eplerenone gained governmental sanction for medicinal use?
"The safety of Eplerenone, which is an approved medication, was rated a 3 due to the late stage nature of this clinical trial."
Answered by AI
Does this trial admit participants younger than 55?
"This clinical trial's entry requirements limit enrolment to those aged between 18 and 69. Conversely, there are 64 trials available for underage patients and 742 specifically targeting the senior demographic."
Answered by AI
What types of volunteers are appropriate for this research trial?
"To gain admission to this study, applicants must have left ventricular hypertrophy and be no older than 69 years of age. Approximately 75 patients will join the trial."
Answered by AI
What is the participant cap for this research project?
"Affirmative. Data hosted on clinicaltrials.gov ascertains that this medical study, which was initially posted on October 20th 2022, is actively enrolling participants. Around 75 prospective patients must be enlisted from a single location."
Answered by AI
Can patients still join this investigation?
"Correct. Clinicaltrials.gov attests that this clinical trial, which was initially announced on October 20th 2022, is presently enrolling participants. Approximately 75 individuals require to be recruited from 1 medical centre."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger