RecruitingOBSERVATIONAL

The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.

The BRAVE study aims to find the genetic reasons behind Bicuspid Aortic Valve (BAV). BAV is a common heart condition where the main valve leaving your heart has two flaps instead of the usual three. This can sometimes make the valve not open or close properly, leading to strain on the heart and potentially needing surgery. We know BAV often runs in families, suggesting a genetic link, but we don't fully understand it. This study will involve collecting blood samples from people with BAV and their relatives. By looking at their genes and comparing them, scientists hope to pinpoint the specific gene changes that cause BAV. This knowledge could help us better understand this important heart condition.

At a glance

Status

Recruiting

Sponsor

University Hospitals, Leicester

Enrolment target

700

Start

08 Sep 2015

Estimated completion

01 Dec 2027

Cardiovascular Diseases

What is this study about?

The BRAVE study is investigating a common heart condition called Bicuspid Aortic Valve, or BAV for short. Normally, the main valve leaving your heart (the aortic valve) has three small flaps that open and close to control blood flow. However, in people with BAV, this valve only has two flaps. This can sometimes cause problems like the valve not opening wide enough, or not closing properly, leading to a leak. Both of these issues can make your heart work harder and might eventually require surgery.

We know that BAV often runs in families, which suggests that genes play a big role in why some people get it. Despite this, we don't fully understand which specific genes are involved or how they lead to BAV. The main goal of the BRAVE study is to figure out these genetic links. By understanding the genes, we hope to learn more about exactly how and why BAV develops.

To do this, the study needs volunteers, including people who have BAV and their family members (who may or may not also have BAV). We will take a blood sample from each participant. By comparing the genetic information from these blood samples with what we know about who has BAV and who doesn't, we hope to find the specific gene changes that are responsible for this condition. This research is really important because a better understanding of BAV could lead to new ways to help people with this condition in the future.

Key takeaways

The BRAVE study investigates genetic causes of Bicuspid Aortic Valve (BAV).
BAV is a common heart valve condition, often running in families.
Participation involves providing a single blood sample.
The study seeks people with BAV and their close relatives aged 10 and over.
Understanding BAV's genetic roots could improve future care.
There are minimal risks, mainly from the blood draw.

Who may be eligible?

You might be able to join the BRAVE study if you are 10 years old or older and have been diagnosed with Bicuspid Aortic Valve (BAV). The study is also looking for your close family members, like your parents, children, or siblings, whether they have BAV or not, as long as they are also aged 10 or older.

However, there are a few reasons why you might not be able to take part. For instance, if you are unable to understand and agree to participate (give informed consent), or if you have certain infections that could be passed on through blood samples, you wouldn't be able to join.

Additionally, if you have known genetic conditions that affect your chromosomes, or certain inherited syndromes like Marfan syndrome, Loeys-Dietz syndrome, or Ehlers-Danlos syndrome, you would not be eligible. This is because these conditions can also affect the heart and could make it harder to find the specific genes linked to BAV.

Quick self-check

Do I have a diagnosis of Bicuspid Aortic Valve (BAV), or am I a close relative of someone who does?
Am I 10 years old or older?
Can I understand what the study involves and agree to take part?
Do I know if I have certain infections like HIV or Hepatitis B/C?
Do I have any known conditions affecting my chromosomes or syndromes like Marfan syndrome?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the BRAVE study, it's quite straightforward. The main thing you'll be asked to do is provide a blood sample. This is similar to a standard blood test you might have at your doctor's surgery or hospital. There are no specific visits required beyond the one where your blood is taken, and you won't need to take any new medications or have any special follow-up appointments directly related to this study. The total duration of your active participation will be limited to the time it takes to give your blood sample.

Potential risks and benefits

Taking part in this study could help us better understand Bicuspid Aortic Valve, which might lead to better ways of diagnosing or treating this condition in the future, although there's no direct personal benefit expected for you. The main risk involves giving a blood sample, which carries a small chance of bruising, minor pain, or very rarely, infection at the site where the needle was inserted. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Kettering General Hospital
Kettering, United Kingdom· Recruiting
University Hospitals of Leicester
Leicester, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
London, United Kingdom· Recruiting
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, United Kingdom· Recruiting

Common questions

What is Bicuspid Aortic Valve (BAV)?

BAV is a common heart condition where the main valve leaving your heart (aortic valve) has two flaps instead of the usual three. This can sometimes cause problems with blood flow.

Why is this study important?

BAV often runs in families, suggesting it's genetic. This study aims to find the specific genes involved, which could help us understand and treat BAV better in the future.

What will I have to do if I join?

If you join, the main thing you'll do is provide a blood sample, just like a regular blood test. That's usually all that's involved.

Will I find out my genetic results?

The study aims to understand BAV on a group level, not to provide individual genetic results. You won't receive individual feedback on your genes from this study.

Can my children take part?

Yes, if your children are 10 years old or older, they may be eligible to participate, whether they have BAV or not.

How to find out more

Aidan Bolger, Dr

aidan.bolger@uhl-tr.nhs.uk Official trial record

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