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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for individuals with obesity who also have high blood pressure and related health issues. The researchers aim to determine if eplerenone, a medication, can improve heart health compared to a treatment consisting of chlorthalidone and potassium chloride. The focus is on enhancing heart function, not merely lowering blood pressure. Suitable participants have a BMI of 30 or higher, or a BMI of 25 with additional conditions such as high blood pressure or cholesterol issues. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

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.

What is the safety track record for these treatments?

Previous studies have shown that the combination of chlorthalidone and potassium chloride effectively lowers blood pressure. Most people tolerate it well, but there is a risk of low potassium levels, which potassium chloride helps prevent.

Research has shown that eplerenone also reduces blood pressure, particularly in overweight individuals. However, it can cause high potassium levels, which may be serious. Doctors typically monitor potassium levels closely when using this medication.

Both treatments have been used extensively, providing a wealth of safety information. It is important to discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for high blood pressure in obesity because they offer potentially more tailored approaches. Chlorthalidone with potassium chloride combines a diuretic with potassium to counteract potassium loss, which is a common issue with standard diuretics like hydrochlorothiazide. This combination might reduce side effects while effectively managing blood pressure. On the other hand, Eplerenone, a selective aldosterone blocker, works differently than typical antihypertensives by specifically targeting hormone pathways that contribute to high blood pressure, which could offer benefits for those with obesity-related hypertension. These unique mechanisms provide promising new options compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for high blood pressure in obesity?

In this trial, participants will receive either chlorthalidone with potassium chloride or eplerenone. Research has shown that chlorthalidone, when combined with potassium chloride, effectively lowers blood pressure. Studies have found it outperforms similar medications in reducing both systolic and diastolic blood pressure. Eplerenone is also effective, particularly for individuals with obesity, and matches the efficacy of other well-known treatments for high blood pressure. Overall, both treatments have proven effective in managing high blood pressure, making them promising options for people with obesity. ^{1 5 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7932752/

Network meta-analysis of efficacy and safety of chlorthalidone ... Our analysis shows that chlorthalidone reduced the serum potassium levels with WMD (95% CI) equal to −0.23 mEq/L (−0.27, −0.19) compared with ...

2. nature.com nature.com/articles/s41371-019-0255-2

Comparative efficacy and safety of chlorthalidone ... CTLD at the doses studied is a more potent antihypertensive agent resulting in greater BP lowering and better outcomes so that recent data in ...

3. ahajournals.org ahajournals.org/doi/10.1161/01.hyp.0000203309.07140.d3

Comparative Antihypertensive Effects of ... Chlorthalidone is more effective in lowering systolic BPs than hydrochlorothiazide, as evidenced by 24-hour ambulatory BPs.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03928145?term=AMILORIDE%20AND%20HYDROCHLOROTHIAZIDE&viewType=Table&rank=1

Efficacy of Chlorthalidone and Hydrochlorothiazide ... This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide , in combination with amiloride in different doses ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084478/

A Randomized Comparative Trial of Losartan/Chlorthalidone ... The study showed that both combinations are effective for hypertension, with losartan/chlorthalidone demonstrating greater efficacy in reducing diastolic blood ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/chlorthalidone-oral-route/description/drg-20071817

Chlorthalidone (oral route) - Side effects & dosage Chlorthalidone is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure.

7. goodrx.com goodrx.com/chlorthalidone/interactions?srsltid=AfmBOooxypg0QxVZwXDOSFpfURl_9oVIzr9L9fytDYNNvBR5OxAVfquV

Chlorthalidone Interactions You Should Know About And combining chlorthalidone with a corticosteroid can raise the risk of low potassium levels (hypokalemia).

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553174/

Chlorthalidone - StatPearls - NCBI Bookshelf - NIH Chlorthalidone is a thiazide-like diuretic used to treat hypertension. This activity discusses chlorthalidone's indications and contraindications.