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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Candesartan can help manage high blood pressure related to obesity. Researchers aim to understand how obesity might affect certain receptors in the body related to high blood pressure. Participants will receive either Candesartan or a placebo (an inactive pill) for seven days to measure its effects. Those with high blood pressure due to obesity who do not take certain heart or blood medications might be a good fit. As an Early Phase 1 trial, this research focuses on understanding how Candesartan works in people, offering a chance to contribute to groundbreaking research.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that candesartan is generally safe and effective for treating high blood pressure, particularly in individuals with obesity. Studies have found that candesartan lowers the risk of stroke and other heart-related issues more effectively than some other medications. It also appears to reduce the likelihood of developing diabetes in obese individuals.

These findings suggest that candesartan could be a safe option for managing high blood pressure in obese individuals. However, this study is in an early stage, focusing primarily on its safety and tolerability. While candesartan is already used to treat high blood pressure, this trial specifically examines its effects on people with obesity. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard blood pressure medications, such as ACE inhibitors and beta-blockers, Candesartan is unique because it specifically blocks the angiotensin II receptor, which plays a key role in regulating blood pressure. Researchers are excited about Candesartan for high blood pressure in obesity because it targets the renin-angiotensin-aldosterone system (RAAS) with precision, potentially offering better cardiovascular protection. Additionally, Candesartan's ability to show effects in just seven days is promising for quicker control of high blood pressure compared to other treatments that may take longer to become effective.

What evidence suggests that candesartan might be an effective treatment for high blood pressure in obesity?

Research has shown that candesartan, which participants in this trial may receive, effectively lowers high blood pressure, particularly in obese individuals. Studies have found that it also reduces the risk of developing diabetes in these individuals. Candesartan blocks certain chemicals that tighten blood vessels, thereby reducing blood pressure. It also decreases inflammation and improves insulin use, which is important for heart health. Overall, candesartan appears promising for managing high blood pressure related to obesity. ^{1 2 4 5 6}

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. nature.com nature.com/articles/hr201038

Role of diabetes and obesity in outcomes of the ... Candesartan treatment may suppress all-cause death and reduce the incidence of new-onset diabetes in patients with obesity. Similar content ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3202428/

An overview of candesartan in clinical practice - PMC The TROPHY study showed that candesartan could reduce the chances of developing hypertension in prehypertension subjects. However, larger scale clinical outcome ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00775814

Efficacy of Candesartan on Reducing Blood Pressure in ... The purpose of this study is to determine the efficacy of candesartan, once daily (QD), combined with hydrochlorothiazide to lower blood ...

4. withpower.com withpower.com/trial/early-phase-1-hypertension-4-2018-29eda

Candesartan for High Blood Pressure in Obesity 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527305010831

Anti-inflammatory and metabolic effects of candesartan in ... Conclusions. Candesartan therapy significantly reduced inflammation and increased adiponectin levels and improved insulin sensitivity in hypertensive patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2922318/

Blood pressure-independent effect of candesartan on ... Candesartan had more beneficial effect in reducing CVD than losartan in obese patients. Compared with the losartan group, the candesartan group had a lower ...