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Study Comparing Eplerenone and Irbesartan for Lowering Blood Pressure in Obese Patients with Hypertension

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different treatments for hypertension, which is a condition characterized by high blood pressure. The study compares two treatment strategies: one based on the medication eplerenone and the other on irbesartan. Both medications are commonly used to help lower blood pressure in patients with hypertension.

The purpose of the study is to determine which treatment strategy is more effective in managing blood pressure in patients who are both obese and have hypertension. Participants in the study will receive either eplerenone or irbesartan, and their blood pressure will be monitored over a period of time to assess the effectiveness of each treatment. The study will also involve the use of a placebo to help compare the results.

Throughout the study, participants will take their assigned medication orally, and their progress will be tracked over several weeks. The study aims to provide valuable information on how these medications can help manage blood pressure in patients with specific health conditions, ultimately contributing to better treatment options for those with hypertension.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes measuring blood pressure and body mass index (BMI).
Eligibility criteria include being between 30 and 75 years old, having a BMI between 30 and 39.99 kg/m², and specific blood pressure ranges.
Step 2
Medication administration
Participants are assigned to one of two treatment strategies: eplerenone-based or irbesartan-based treatment.
The medications are administered orally in the form of tablets or capsules.
Step 3
Medication details
For the eplerenone-based strategy, the medication Inosamin (eplerenone) is used at a dosage of 25 mg.
For the irbesartan-based strategy, the medication LUCIDEL (irbesartan) is used at a dosage of 150 mg.
Step 4
Additional medications
Additional medications may include Fludex (indapamide) at 1.5 mg and Amlopen (amlodipine) at 5 mg, both administered orally.
Step 5
Monitoring and follow-up
Participants undergo regular monitoring to assess blood pressure changes over 24-hour periods.
The primary goal is to evaluate the effectiveness of the treatment in lowering blood pressure.
Step 6
Study duration
The study is expected to conclude by June 30, 2025.
Participants will be involved in the study until its completion or until they choose to withdraw.

Who can join the trial?

5 criteria

Age between 30 and 75 years.
Have a **systolic blood pressure** (the top number in a blood pressure reading) between 140 and 179 mmHg, or a **diastolic blood pressure** (the bottom number) between 90 and 119 mmHg.
Average **24-hour systolic blood pressure** greater than 130 mmHg, or average **24-hour diastolic blood pressure** greater than 80 mmHg. This means your blood pressure is measured over a full day to get an average reading.
Have a **Body Mass Index (BMI)** between 30 and 39.99 kg/m². BMI is a number calculated from your weight and height to see if you are in a healthy weight range.
Be able to understand and agree to participate in the study.

Who cannot join the trial?

4 criteria

People who have **high blood pressure** (also known as **hypertension**) cannot participate.
Individuals who are not within the age range specified for the study are excluded. The study is open to adults, which typically means people aged 18 and older.
Both **men and women** can participate, so gender is not a reason for exclusion.
People who are considered part of a **vulnerable population** are not excluded, meaning the study does not specifically exclude groups like pregnant women or those with certain disabilities.

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Verified sites

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Laiko General Hospital Of Athens
Athens, Greece

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Investigated drugs

Eplerenone
is a medication used in this study to help lower blood pressure. It works by blocking certain hormones in the body that can raise blood pressure. This medication is often used to treat high blood pressure and heart failure.
Irbesartan
is another medication involved in the study, which is also used to lower blood pressure. It belongs to a class of drugs called angiotensin receptor blockers (ARBs). Irbesartan helps relax blood vessels, making it easier for the heart to pump blood, which can help reduce blood pressure.

What is already known about the treatment

Eplerenone
Eplerenone is administered orally in tablet form and is currently used in the medical field to manage hypertension, particularly in patients who are obese. It is classified as a selective aldosterone receptor antagonist, which means it works by blocking the action of aldosterone, a hormone that increases blood pressure by causing the body to retain sodium and water. By inhibiting this hormone, eplerenone helps to lower blood pressure and reduce the risk of cardiovascular events.
Irbesartan
Irbesartan is also taken orally in tablet form and is widely recognized in medical literature for its effectiveness in treating hypertension. It belongs to a class of drugs known as angiotensin II receptor blockers (ARBs), which function by preventing angiotensin II from binding to its receptors, thereby relaxing blood vessels and lowering blood pressure. This medication is particularly beneficial for patients with high blood pressure who are at risk of heart-related complications.

Investigated diseases

Hypertension – Hypertension, also known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. Over time, this increased pressure can cause damage to the blood vessels and organs, particularly the heart, brain, kidneys, and eyes. It often develops over many years and can go unnoticed due to a lack of symptoms. As it progresses, it may lead to complications such as heart disease or stroke. Regular monitoring of blood pressure is essential to manage and understand the progression of this condition.