AuthorisedTherapeutic use (Phase IV)Interventional

Comparative study of eplerenone-based treatment strategy versus irbesartan-based blood pressure lowering in obese hypertensive patients (HEBRO Study)

The HEBRO Study is investigating the best way to manage high blood pressure in people who are also obese. It's comparing two established strategies that involve different types of blood pressure medications: one based on eplerenone and another based on irbesartan. Researchers want to see which approach is more effective at lowering and controlling blood pressure over a 24-week period. They will measure blood pressure regularly, both in a clinic setting and using a special monitor that patients wear for 24 hours. The study is a 'Phase IV' trial, which means it's looking at how well existing, approved treatments work in real-world settings. Understanding this could help doctors make better choices for patients with both obesity and high blood pressure.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Institute For Study Research Education And Therapy Of Vascular Heart Brain And Kidney Nosologies

Enrolment target

198

Start

21 Jan 2025

Hypertension

What is this study about?

This research, called the HEBRO Study, is looking into the best ways to treat high blood pressure in people who also have obesity. High blood pressure, sometimes called hypertension, means your heart has to work harder to pump blood around your body, which can lead to serious health problems over time. Obesity can also increase the risk of high blood pressure.

The study compares two different approaches to lowering blood pressure. One approach uses a medication called eplerenone, and the other uses a medication called irbesartan. Both are well-known types of medicine for high blood pressure. Researchers want to find out if one of these strategies is more effective than the other at bringing blood pressure down and keeping it stable over about six months.

They're particularly interested in how these treatments affect blood pressure throughout a full day, using a special device patients wear, as well as regular checks at the doctor's office. This knowledge will help doctors make more informed decisions when treating patients who have both high blood pressure and obesity.

Key takeaways

The study compares two common strategies for treating high blood pressure in obese patients.
It aims to find out which approach (eplerenone-based or irbesartan-based) is more effective.
Participation involves taking medication and having regular blood pressure checks, including 24-hour monitoring.
The study lasts for about 24 weeks (6 months).
It's a 'Phase IV' study looking at approved treatments in real-world settings.

Who may be eligible?

To take part in this study, you need to be an adult, which means 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.

The study is open to both men and women.

The main focus is on individuals who have high blood pressure and are also medically considered obese. Specific details about your health and other medications you might be taking would be checked by the study team to make sure it's safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high blood pressure?
Do you also have obesity?
Are you prepared to take medication as prescribed by the study team?
Are you able to attend appointments and wear a 24-hour blood pressure monitor occasionally?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for about 24 weeks, which is roughly six months. During this time, you would be given one of the study medications to take regularly. You would have several visits to the clinic where your blood pressure would be measured by a doctor or nurse. Most importantly, you would occasionally wear a special monitor for 24 hours that records your blood pressure as you go about your daily activities. This helps researchers understand how the medication affects your blood pressure throughout the day and night. The study team would also check your general health and any side effects you might experience.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical monitoring and access to supervised treatment strategies for your high blood pressure. There's a chance that one of the treatments might be particularly effective for you. However, as with any medication, there are potential risks, including side effects from the drugs. These will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is high blood pressure?

High blood pressure is when the force of your blood pushing against the walls of your arteries is consistently too high. This can put a strain on your heart and blood vessels.

What does a 'Phase IV' study mean?

A Phase IV study means the treatments being tested are already approved and available. Researchers are studying them further to see how well they work in different groups of people or in real-world situations, rather than just in initial tests.

What is '24-hour ambulatory blood pressure'?

This is a way to measure your blood pressure regularly over a full day and night using a small device you wear. It gives a more complete picture of your blood pressure than just a single reading at the doctor's office.

Will I know which treatment I'm getting?

Sometimes in studies like this, patients are randomly assigned to a treatment group, and neither you nor your doctor will know which one you are receiving until the study is over. The study team will explain how this works.

What kind of medications are eplerenone and irbesartan?

Both eplerenone and irbesartan are established medications used to treat high blood pressure, but they work in slightly different ways to help relax blood vessels and lower pressure.