Active not recruitingNAINTERVENTIONAL

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

This study is about people who have a leaky heart valve, called mitral regurgitation, which is caused by problems with the heart muscle due to blocked arteries. Normally, surgeons either fix (repair) or swap out (replace) this leaky valve. However, we don't really know for sure which method is best for different people. At the moment, surgeons often choose based on their own experience or what they prefer to do. This research will compare two ways of deciding treatment: some patients will have their treatment decided in the usual way (surgeon's preference), while others will have theirs decided by a special set of guidelines, or 'algorithm,' which uses precise measurements of their valve. The aim is to see if patients whose treatment was guided by these rules do better over 12 months after their surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

110

Start

16 Jan 2018

Estimated completion

01 Nov 2028

Mitral Regurgitation

What is this study about?

This study is looking into the best way to treat a condition called 'ischemic mitral regurgitation.' This happens when the heart's mitral valve, which helps blood flow in the right direction, becomes leaky. This leakiness is caused by damage to the heart muscle, often due to narrowed or blocked arteries (coronary artery disease).

When someone has this leaky valve, surgeons usually try to fix it, either by repairing the existing valve or by replacing it with a new one. However, doctors don't have very clear instructions or strong evidence yet to tell them exactly which patients will do better with a repair and which will do better with a replacement. Because of this, the decision often comes down to the individual surgeon's experience or personal choice. Dr. Vincent Chan, a lead researcher in this study, and some other surgeons believe it would be better to make this decision based on specific measurements of the heart valve.

To find the best approach, this study will divide patients into two groups. One group will get the usual treatment, where the surgeon decides whether to repair or replace the valve based on their experience. The other group will have their treatment decided by a special set of rules, often called an 'algorithm,' which uses detailed measurements of their mitral valve to guide the decision. All patients will be followed for 12 months after their surgery to see if one approach leads to better health and recovery than the other. This will help doctors understand if using a guided approach improves patient outcomes.

Key takeaways

This study compares two ways of deciding treatment for a leaky heart valve.
It aims to see if specific guidelines improve patient outcomes after surgery.
Patients will either receive treatment based on surgeon preference or a guided approach.
All participants receive either a mitral valve repair or replacement.
The study follows patients for 12 months after their operation.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old and have a specific severe heart condition called 'ischemic mitral regurgitation.' This means you have a very leaky mitral valve that's caused by problems with your heart muscle, often due to blocked arteries.

You also need to be able to fully understand what the study involves and agree to take part. This is called 'informed consent.'

There are a few reasons why you might not be able to join. For example, if your leaky valve is caused by other heart problems, not just the heart muscle issues (this is called 'mixed mitral valve pathology'). You also can't join if your leaky valve developed very recently or suddenly (this is called 'acute ischemic mitral regurgitation').

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 severe ischemic mitral regurgitation (a very leaky mitral valve due to heart muscle damage)?
Is your leaky valve *only* due to heart muscle damage, not other reasons?
Did your leaky valve problem develop over time, not suddenly?
Are you able to understand the study and give your agreement to join?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two groups. One group will have their leaky mitral valve repaired or replaced based on your surgeon's usual judgment. The other group will have the decision about repair or replacement guided by a specific set of measurements and rules, known as an algorithm. After your surgery, both groups will be followed up for a total of 12 months. This will involve regular checks to see how well you are recovering and how your heart is doing. The study doesn't specify extra visits beyond standard follow-up after heart surgery, but any needed assessments will be explained by the study team. You will receive either a valve repair or replacement as part of your treatment.

Potential risks and benefits

Taking part in any study involves careful consideration. A potential benefit of this study is helping doctors better understand how to treat severe leaky heart valves, which could lead to better outcomes for future patients. For you personally, if you are in the group whose treatment is guided by specific rules, it's hoped that this might lead to the best possible outcome for your surgery. However, as with any major surgery, there are always risks involved, such as those related to the surgery itself and recovery. You will receive treatment that is already an accepted way of dealing with your condition. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada

Common questions

What is ischemic mitral regurgitation?

It's a condition where one of your heart valves (the mitral valve) is leaky because of damage to your heart muscle, often from narrowed arteries.

What's the main question this study is trying to answer?

It wants to find out if using a specific guide to decide between repairing or replacing a leaky heart valve leads to better results for patients.

Will I get to choose if my valve is repaired or replaced?

The study will randomly assign you to a group where the surgeon decides, or a group where a guide decides. You won't choose the specific treatment method within the study.

How long will I be involved in the study?

You'll be followed up for 12 months after your heart surgery.

What's an 'algorithm' in this study?

It's a set of rules or guidelines that helps doctors decide the best treatment (repair or replacement) based on measurements of your heart valve.