AuthorisedTherapeutic exploratory (Phase II)Interventional

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2

This research is investigating a new treatment for people whose high blood pressure isn't well-controlled with their current medications. The study is testing a drug called bosentan, which comes in two different strengths. Researchers want to see if this new treatment can help blood vessels in the arm relax more effectively, allowing blood to flow better, over an 8-week period. They will also look at how it affects blood pressure in general, the stiffness of blood vessels, and how the kidneys are working. This is an early-stage study, meaning it's exploring whether the treatment works and is safe before larger studies are done.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

Start

19 Aug 2024

Uncontrolled arterial hypertension

What is this study about?

This study is for people who have high blood pressure that isn't being properly controlled by their current medicines. High blood pressure, also known as hypertension, can put a strain on your heart and blood vessels if it's not managed well.

The researchers are investigating a new way to tackle this problem by focusing on a substance in your body called endothelin-1. This substance can make blood vessels تنگ (narrow), which then increases blood pressure. The study is testing a medication called bosentan, which aims to block the effects of endothelin-1, helping your blood vessels to relax and open up.

Over 8 weeks, the study will look at how this medication affects the tiny blood vessels in your arm. They want to see if it helps these vessels widen more easily and improves blood flow. They will also check if it lowers both your overall blood pressure and the stiffness of your arteries, as well as how well your kidneys are working.

Key takeaways

This study is testing a new drug, bosentan, for uncontrolled high blood pressure.
It aims to see if the drug helps blood vessels relax and improves blood flow.
The study lasts 8 weeks and involves regular check-ups.
Both men and women aged 18 and over with uncontrolled high blood pressure can take part.
It's an early-stage study to explore the treatment's effects and safety.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to participate in this research. The main requirement is that you have high blood pressure that hasn't been brought under control with the usual treatments.

The research team will carry out some checks to make sure the study is a good fit for you and that it's safe for you to take part. They will look at your full medical history and current health before you can 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 that isn't well-controlled by your current medicines?
Are you able to attend regular clinic visits for 8 weeks?
Are you comfortable with taking a study medication (which might be a placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given one of two strengths of the study drug, bosentan, or a neutral tablet that looks like the study drug (a placebo). The study lasts for 8 weeks. During this time, you would have regular visits to the clinic.

At these visits, the research team would check your blood pressure and may also take blood and urine samples. They will also perform some special tests to measure how well your blood vessels are relaxing and how blood is flowing. They will also assess the stiffness of your blood vessels and how your kidneys are functioning.

It's important to attend all scheduled visits and take the study medication as instructed. The total duration of your participation in the study is 8 weeks.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, and it helps doctors learn more about controlling high blood pressure. While we hope the treatment will be beneficial, we can't guarantee you will personally experience an improvement. There are potential risks, as with any medication, such as side effects, which the study team will fully explain. You are free 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
France

Common questions

What is high blood pressure?

High blood pressure (hypertension) means your heart has to work harder to pump blood around your body, which can damage blood vessels over time.

What is bosentan?

Bosentan is a medication that aims to help blood vessels relax by blocking a certain substance in your body that can make them narrow.

How long will the study last for me?

Your involvement in the study will last for 8 weeks.

Will I know if I'm getting the real drug or a placebo?

No, you won't know whether you're receiving the active drug or a placebo, nor will the study doctors, to keep the results unbiased.

What if my blood pressure gets worse during the study?

Your health will be closely monitored, and if your blood pressure changes significantly or if you experience any concerning symptoms, the study team will take appropriate action.