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Thiazide Diuretic

Blood Pressure Medications for High Blood Pressure in Obesity

Phase 4
Waitlist Available
Led By Anand Vaidya, MD
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
Age between 18 and 70 years old
BMI ≥ 30 with at least one of the following, or BMI ≥ 25 with at least two of the following:
Must not have
Known history of CVD (myocardial infarction, heart failure, atrial fibrillation, or stroke)
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of two different blood pressure medications on heart function.

Who is the study for?
This trial is for adults aged 18-70 with obesity (BMI ≥ 30) and at least one cardiovascular risk factor like untreated hypertension, or a BMI ≥ 25 with two such factors. Participants should not have diabetes, known heart disease history, severe kidney issues, high potassium levels, or be pregnant/breastfeeding.
What is being tested?
The study tests if eplerenone can improve heart muscle blood flow and reduce scarring better than chlorthalidone plus potassium chloride in obese individuals with high aldosterone production, without considering changes in blood pressure.
What are the potential side effects?
Eplerenone may cause increased potassium levels leading to abnormal heart rhythms, dehydration due to frequent urination; Chlorthalidone could lead to dehydration as well and low potassium which might also affect the heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My BMI is 30 or higher with at least one health issue, or it's 25 or higher with at least two.
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My fasting triglycerides are over 150 mg/dL and my HDL is low.
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My blood pressure is between 120/80 and 159/99 mmHg and untreated.
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My blood pressure is between 120-139/80-89 or 140-159/90-99 mmHg and untreated.

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 disease, including heart attack, failure, irregular heartbeat, or stroke.
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My kidney function is reduced.
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I have been diagnosed with or treated for diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year 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 stress myocardial perfusion reserve on cardiac MRI
Secondary study objectives
Change in extracellular volume fraction on cardiac MRI

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%
Constipation
1%
Pericarditis
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EplerenoneExperimental Treatment1 Intervention
Participants will receive eplerenone, ranging from 25-100mg daily for one year.
Group II: Chlorthalidone with potassium chlorideActive Control1 Intervention
Participants will receive chlorthalidone (6.25-25mg daily for one year) along with potassium chloride (up to 20 mEq daily for one year)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eplerenone
2015
Completed Phase 4
~6640

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,664 Previous Clinical Trials
11,834,906 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
28,983 Patients Enrolled for Metabolic Syndrome
Anand Vaidya, MDPrincipal Investigator - Brigham and Women's Hospital, Harvard Medical School
Boston Children's Hospital, Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Brigham & Women'S Hospital (Residency)
2 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Chlorthalidone with potassium chloride (Thiazide Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04519164 — Phase 4
Metabolic Syndrome Research Study Groups: Chlorthalidone with potassium chloride, Eplerenone
Metabolic Syndrome Clinical Trial 2023: Chlorthalidone with potassium chloride Highlights & Side Effects. Trial Name: NCT04519164 — Phase 4
Chlorthalidone with potassium chloride (Thiazide Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04519164 — Phase 4
~16 spots leftby Nov 2025
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