Blood Pressure Medications for High Blood Pressure in Obesity

Overseen By Anand Vaidya, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Disqualifiers: Diabetes, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate whether the mineralocorticoid receptor antagonist eplerenone, when compared to chlorthalidone plus potassium chloride, can improve cardiac MRI-derived myocardial perfusion reserve and fibrosis, independent of blood pressure, and proportionately to the severity of autonomous aldosterone production.

Will I have to stop taking my current medications?

If you are currently taking one blood pressure medication, you will need to stop it for a 2-week period before starting the trial medications.

Is the treatment with chlorthalidone and eplerenone safe for humans?

Chlorthalidone is generally safe for humans, but it can cause some side effects like hypokalemia (low potassium levels) and glucose intolerance, especially at higher doses. A lower dose formulation has fewer metabolic side effects, making it a safer option for managing high blood pressure. ^{1 2 3 4 5}

How is the drug combination of Chlorthalidone with potassium chloride and Eplerenone unique for treating high blood pressure in obesity?

This drug combination is unique because Eplerenone, an aldosterone blocker, may help reduce blood pressure and improve body measurements like BMI and waist circumference in people with obesity, while Chlorthalidone helps reduce blood pressure and may decrease heart muscle mass, offering a dual approach to managing high blood pressure in obese patients. ^{1 4 6 7 8}

What data supports the effectiveness of the drug Chlorthalidone with potassium chloride, Eplerenone, Inspra for high blood pressure in obesity?

Research shows that chlorthalidone, a component of the treatment, is effective in reducing left ventricular mass in patients with high blood pressure, which is beneficial for heart health. Additionally, obese individuals with high blood pressure often require multiple medications, including thiazide diuretics like chlorthalidone, to effectively manage their condition. ^{1 3 9 10 11}

Who Is on the Research Team?

Anand Vaidya, MD

Principal Investigator

Brigham and Women's Hospital, Harvard Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is 30 or higher with at least one health issue, or it's 25 or higher with at least two.

My fasting triglycerides are over 150 mg/dL and my HDL is low.

I have high blood pressure controlled by one medication and am willing to stop it for 2 weeks for a study.

Exclusion Criteria

I have a history of heart disease, including heart attack, failure, irregular heartbeat, or stroke.

My kidney function is reduced.

Pregnancy (verified with a pregnancy test) or breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Deep-phenotyping

Participants undergo a deep-phenotyping protocol to characterize aldosterone and cortisol physiology before randomization

2-4 weeks

Treatment

Participants are randomized to receive either eplerenone or chlorthalidone plus potassium chloride for one year

52 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chlorthalidone with potassium chloride
• Eplerenone

Trial Overview 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.

How Is the Trial Designed?

Group I: Eplerenone Experimental Treatment 1 Intervention

Participants will receive eplerenone, ranging from 25-100mg daily for one year.

Group II: Chlorthalidone with potassium chloride Active Control 1 Intervention

Participants will receive chlorthalidone (6.25-25mg daily for one year) along with potassium chloride (up to 20 mEq daily for one year)

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Blood pressure control and cardiovascular outcomes in normal-weight, overweight, and obese hypertensive patients treated with three different antihypertensives in ALLHAT. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Antihypertensive Effectiveness of Perindopril Arginine and Indapamide Single-Pill Combination According to Body Mass Index: Findings from the FORSAGE Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Secondary hypertension: obesity and the metabolic syndrome. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of withdrawal of antihypertensive drug on depressive mood. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

[Effect of treatment with chlorthalidone on reduction of left ventricular mass in patients with systemic arterial hypertension]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperaldosteronism as a common cause of resistant hypertension. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results from the PREVER-treatment randomized trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and reduced metabolic side effects of a 15-mg chlorthalidone formulation in the treatment of mild hypertension. A multicenter study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of eplerenone on blood pressure and glucose metabolism in Japanese hypertensives with overweight or obesity. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Angiotensin II receptor blocker combined with eplerenone or hydrochlorothiazide for hypertensive patients with diabetes mellitus. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Intrapatient comparison of treatment with chlorthalidone, spironolactone and propranolol in normoreninemic essential hypertension. [2019]