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Thiazide Diuretic

Blood Pressure Medications for High Blood Pressure in Obesity

Phase 4
Recruiting
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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have high blood pressure controlled by one medication and am willing to stop it for 2 weeks for a study.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in stress myocardial perfusion reserve on cardiac MRI
Secondary outcome measures
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%
Cough
3%
Angina pectoris
3%
Abdominal pain upper
3%
Non-cardiac chest pain
2%
Dyspnoea
2%
Anxiety
2%
Hypertension
2%
Bradycardia
2%
Ventricular tachycardia
2%
Fatigue
2%
Oedema peripheral
2%
Diabetes mellitus
2%
Back pain
2%
Headache
1%
Cardiac failure
1%
Pericarditis
1%
Constipation
1%
Nausea
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
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
1,602 Previous Clinical Trials
11,463,145 Total Patients Enrolled
45 Trials studying Obesity
78,095 Patients Enrolled for Obesity
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
1 Trials studying Obesity
26 Patients Enrolled for Obesity

Media Library

Chlorthalidone with potassium chloride (Thiazide Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04519164 — Phase 4
Obesity Research Study Groups: Chlorthalidone with potassium chloride, Eplerenone
Obesity 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional investigations involving Eplerenone?

"As of now, 39 clinical trials are researching the efficacy of Eplerenone. Of these studies, 6 have reached phase 3. Although most experiments related to this drug occur in Nagoya, Aichi, there are 132 worldwide testing sites available."

Answered by AI

To what medical conditions is Eplerenone most commonly prescribed?

"Eplerenone is frequently employed to reduce edema, and can also be effective for treating kidney diseases, terminal state maladies, and myocardial infarction."

Answered by AI

Is this research project currently accessible to participants?

"Per the information posted on clinicaltrials.gov, this medical investigation is in search of subjects to further their research. The trial was inaugurated December 1st 2020 and last updated February 28th 2022."

Answered by AI

Could I potentially partake in this clinical endeavor?

"This clinical trial requires 80 participants aged between 18 to 70 years old, who are currently affected by metabolic syndrome. Eligibility criteria also stipulates that all patients must fall in the aforesaid age range."

Answered by AI

How many test subjects are currently participating in the experiment?

"Indeed, the information available on clinicaltrials.gov states that this investigation is actively scouting for participants. It was initially posted in December 2020 and most recently updated at the end of February 2022; it aims to gather 80 individuals from a single site."

Answered by AI

Is the elderly demographic being considered for inclusion in this experiment?

"Participants hoping to be considered for this medical trial must fall within the age bracket of 18-70. On the other hand, there are 300 studies available for minors and 1745 trials catered towards seniors."

Answered by AI

What risks are associated with the ingestion of Eplerenone?

"Data indicates that eplerenone has been approved for use, thus receiving a safety score of 3."

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?
2
~27 spots leftby Nov 2025