Candesartan for High Blood Pressure in Obesity

(END-RF Trial)

Overseen By Ryan Harris, PhD, CES

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Augusta University

Must not be taking: Nitrates, Anticoagulants

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

Compensation: Varies

Number of Visits: 1

Duration: 1 week

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will use chemicals and a drug called Candesartan to study how they affect certain receptors related to blood pressure. It focuses on obese individuals who often have high levels of a substance called ET-1, which is linked to high blood pressure. By blocking these receptors, the study aims to see if it can improve their function and help lower blood pressure in obese people. Candesartan has been studied extensively for its effects on blood pressure, particularly in hypertensive and obese patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect blood vessel function, like nitrates, and any blood thinners, such as aspirin.

Is Candesartan safe for humans?

Candesartan has been studied for its safety in treating high blood pressure, especially in people with obesity. It may reduce the risk of new-onset diabetes and has been associated with lower all-cause mortality compared to some other treatments, like amlodipine, in obese patients. ^{1 2 3 4 5}

How does the drug Candesartan differ from other treatments for high blood pressure in obesity?

Candesartan is unique because it blocks the angiotensin II receptor, which helps reduce blood pressure by relaxing blood vessels and decreasing the activity of the renin-angiotensin system, a key factor in obesity-related hypertension. This mechanism also offers potential benefits for improving insulin sensitivity and protecting organs like the heart and kidneys, which are often affected in obese individuals with high blood pressure. ^{1 5 6 7 8}

What evidence supports the effectiveness of the drug Candesartan for treating high blood pressure in people with obesity?

Research suggests that drugs like Candesartan, which block the renin-angiotensin system, may be beneficial for treating high blood pressure in people with obesity. This is because they can help manage the increased activity of this system, which is often linked to obesity-related high blood pressure and other metabolic issues. ^{1 6 9 10 11}

Who Is on the Research Team?

Ryan Harris, PhD

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 who are dealing with high blood pressure and obesity. It's not open to those with cardiovascular, lung, kidney, liver, brain diseases or metabolic disorders; pregnant individuals; people on meds that affect blood vessels or anticoagulants like aspirin; those with anemia, postmenopausal women, or uncontrolled hypertension.

Exclusion Criteria

You are pregnant.

My blood pressure is not controlled, even with treatment.

I have a heart, lung, kidney, liver, brain, or metabolic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Candesartan or placebo for 7 days to assess ETB receptor function

1 week

1 visit (in-person) at baseline, 1 visit (in-person) post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Candesartan
• Placebo

Trial Overview The study is testing the effects of Candesartan (a drug) against a placebo to see if it can improve how well ETB receptors work in obese individuals. This could help understand if these receptors play a role in developing high blood pressure due to obesity.

How Is the Trial Designed?

Group I: Candesartan Experimental Treatment 1 Intervention

Sub chronic (7 days) Candesartan (16 mg/day)

Group II: Placebo Placebo Group 1 Intervention

Endothelial function will be determined following a seven day treatment of placebo

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Obesity is a significant risk factor for hypertension and is often accompanied by issues like insulin resistance and dyslipidemia, which can lead to serious health complications such as left ventricular hypertrophy and increased inflammation.

Antihypertensive medications that target the renin-angiotensin system, like ACE inhibitors and angiotensin receptor blockers, may not only lower blood pressure but also improve metabolic health and protect against organ damage in obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a rationale for angiotensin blockade in the management of obesity hypertension? Sharma, AM.[2016]

Citations

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

Is there a rationale for angiotensin blockade in the management of obesity hypertension? [2016]

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

Diagnosis and management of hypertension in obesity. [2006]

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

Obesity-related hypertension: epidemiology, pathophysiology, and clinical management. [2022]

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

Obesity and hypertension. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative effects of candesartan and hydrochlorothiazide on blood pressure, insulin sensitivity, and sympathetic drive in obese hypertensive individuals: results of the CROSS study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Role of diabetes and obesity in outcomes of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. [2022]

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

The treatment of hypertension in obese patients. [2021]

8. Austria pubmed.ncbi.nlm.nih.gov

[Hypertension and overweight]. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Arterial hypertension in obese patients. Rationale for a prospective medical care study in the family doctor's practice]. [2018]

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

AT1-receptor antagonism reverses the blood pressure elevation associated with diet-induced obesity. [2020]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Pathophysiology and treatment of obesity hypertension. [2022]