RecruitingPHASE4INTERVENTIONAL

Angiotensin Receptor Blockers in Aortic Stenosis

This research is investigating a common heart condition called aortic stenosis, where one of the heart's main valves (the aortic valve) becomes stiff and doesn't open properly. We are particularly interested in whether a type of medication known as Angiotensin Receptor Blockers (ARBs), often used for high blood pressure, could help. Doctors believe that these medicines might slow down the progression of aortic stenosis and reduce stress on the heart. This study aims to find out if ARBs can be effective in people who have a mild to moderate form of this valve problem, helping to keep their hearts healthy and prevent the condition from worsening over time. We'll be comparing people taking ARBs with those taking a dummy pill (placebo) to understand the medicine's real effects.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Enrolment target

144

Start

01 Feb 2020

Estimated completion

01 Feb 2027

Aortic Stenosis Aortic Valve Stenosis

What is this study about?

You've been looking at information about a research study for people with a heart condition called aortic stenosis. This is when the main valve in your heart, which controls blood flow out to your body, becomes stiff and narrow. This can make your heart work harder.

Researchers are interested in a type of medicine called Angiotensin Receptor Blockers, or ARBs for short. These medicines are already used to treat conditions like high blood pressure. Some early studies have suggested that ARBs might do more than just lower blood pressure; they could also help protect the heart and slow down the worsening of aortic stenosis. This is because these medicines might affect certain natural body processes that are thought to play a role in how aortic stenosis progresses.

The main goal of this particular study is to see if ARB medication can effectively slow down the progress of aortic stenosis and help keep the heart muscle healthy. We want to understand if taking an ARB can prevent the valve from getting narrower too quickly and reduce stress on the heart over time in people who have a mild to moderate form of the condition. To do this fairly, some participants will receive the actual ARB medicine, while others will receive a 'dummy' pill (placebo) that looks the same but contains no active medicine.

Key takeaways

This study explores a common blood pressure medicine (ARBs) for aortic stenosis.
It aims to see if ARBs can slow down the worsening of this heart valve condition.
Participants will receive either the study drug or a placebo (dummy pill).
Regular health checks, including heart scans, will be part of the study.
Participation is voluntary, and you can leave the study at any time.
The study focuses on people with mild to moderate aortic stenosis.

Who may be eligible?

To be considered for this study, you would need to have mild to moderate aortic stenosis, meaning your valve is narrowing but not severely. Your heart's pumping function should also be normal, and your blood pressure needs to be within a certain healthy range.

However, there are some reasons why you might not be able to join. For example, if you have other significant heart valve problems, or if you're already taking medicines that work in a similar way to ARBs. You also couldn't join if you have certain kidney or liver problems, uncontrolled diabetes, or severe heart chest pain.

Additionally, if you're pregnant or breastfeeding, have memory problems, or are unable to understand and sign consent forms, you wouldn't be able to take part. The study is open to both men and women between the ages of 20 and 99.

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.

Do you have mild to moderate aortic stenosis?
Is your heart's main pumping function considered normal?
Do you have stable blood pressure, not too low or too high?
Are you NOT currently taking medicines similar to ARBs for another condition?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe problems with your kidneys, liver, or uncontrolled diabetes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the study medication (an ARB) or a dummy pill (placebo). Neither you nor your study doctor would know which one you are taking until the end of the study. This helps ensure fair results. You would have regular check-ups with the study team, involving various assessments like heart scans (echocardiograms) and blood tests, to monitor your heart condition and overall health. The exact frequency and duration of these visits would be explained in full detail by the study team, but they are designed to safely track any changes and the effect of the treatment.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a medication that could slow down the progression of your aortic stenosis and improve your heart's health. However, as with all medications, there might be side effects or risks, which the study team will explain thoroughly. Some people might experience side effects from ARBs, even though they are generally well-tolerated. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

CRIUCPQ
Verified postcode
Québec, Canada· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting

Common questions

What is 'aortic stenosis'?

It's a heart condition where one of the main valves in your heart becomes stiff and narrow, making it harder for blood to flow out of your heart.

What are ARBs?

ARBs (Angiotensin Receptor Blockers) are a type of medicine often used to lower high blood pressure, but we are investigating if they can also help with aortic stenosis.

Will I know if I'm taking the real medicine or a dummy pill?

No, you won't know. This is called 'blinding' and helps us get accurate results by ensuring everyone is treated the same way.

How long will the study last?

The full duration of the study, including all visits and follow-ups, will be explained in detail by the study team before you decide to join.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

Marie-Annick Clavel, PhD

marie-annick.clavel@criucpq.ulaval.ca 418-656-8711 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.