Not yet recruitingOBSERVATIONAL

Genomics in Heart Transplants

This research project is called "Genomics in Heart Transplants" and aims to better understand why some people who have had a heart transplant may develop serious heart issues afterwards, such as a heart attack or issues with blood vessels. Doctors already know that factors like your general health and reason for transplant play a role, but they don't fully understand why some people are more affected than others. To find out more, researchers will study 200 heart transplant patients, looking at detailed health information like their exercise ability, diet, and cholesterol levels. They will also use advanced genetic testing, including a new type called "long-read whole-genome sequencing," on them and their donors. This will help them discover how a person's genes, as well as lifestyle factors, might work together to affect their health after a heart transplant.

At a glance

Status

Not yet recruiting

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

200

Start

01 Jan 2024

Estimated completion

01 Jan 2028

Heart Transplantation

What is this study about?

Heart transplantation is a life-saving operation for people with very serious heart failure when other treatments haven't worked. While many people do very well after a transplant, unfortunately, about one in eight patients still experience serious complications, such as heart attacks or problems with the blood vessels that supply the new heart. Doctors know that some traditional risk factors, like the specific reason someone needed a transplant, can explain some of these issues. However, these factors alone don't fully predict who will develop problems, and the exact reasons why these problems happen are still not well understood. This means there's a real need to understand more about what causes these difficulties.

This study, called "Genomics in Heart Transplants," aims to fill these gaps in our knowledge. Researchers believe that a combination of a person's genes and their lifestyle might play a bigger role than previously thought. To investigate this, they will look at detailed health information from 200 heart transplant patients. This includes things like how well they can exercise, their diet, whether they smoke, and their cholesterol levels. They will also use advanced genetic tests, including a newer method called "long-read whole-genome sequencing." This new testing is better at finding complex genetic differences that older tests might miss.

The study has a few main parts. For 200 patients, they will combine all the health information with genetic tests to see how known genetic risk factors and lifestyle choices interact to affect how well patients do after their transplant. For 100 new transplant patients and their donors, they will use the even more detailed "long-read" genetic testing. This will allow them to look at a wide range of genetic differences, including those related to how the body's immune system accepts the new heart, as well as individual lifestyle factors. By doing this, they hope to get a much clearer picture of what factors contribute to recurring heart problems in people who have had a heart transplant.

Key takeaways

Aims to understand why heart transplant patients sometimes face complications.
Combines detailed health checks with advanced genetic testing.
Will study both the transplant recipients and their organ donors.
Hopes to improve ways to predict and prevent future problems.
Focuses on people aged 18 and over who have had a heart transplant at the study site.

Who may be eligible?

This study is looking for people who are aged 18 or older and have received a heart transplant at the centre where the study is taking place. If you are under 18, you will not be able to take part in this research.

Another important requirement is that you must be able to understand the study information and give your permission to participate. If for any reason someone isn't able to give their consent, they wouldn't be able to join the study.

In summary, if you are an adult (18 or over) who has had a heart transplant at the study's location and can understand and agree to the research, you might be eligible to take part.

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?
Have you had a heart transplant at the hospital running this study?
Are you able to understand the study and agree to take part?
Are you willing for your health information and genetic samples to be used for research?

Answer every question to see your result.

What does participation involve?

The information provided only briefly describes the overall study and does not detail specific visits, assessments, medication, or follow-up schedules for participants. However, it mentions that the study involves collecting detailed health information, such as heart scans (MRI, angiogram), exercise tests, and details about diet, smoking, and cholesterol. It also states that genetic testing (whole-genome sequencing) will be performed. The total duration of participation is not specified, but it implies collecting data at a certain point in time (cross-sectional) and potentially upon receiving a new transplant for some participants.

Potential risks and benefits

Taking part in this study could offer several potential benefits, including helping scientists and doctors understand more about why some heart transplant patients develop complications. This understanding could lead to better ways to predict and prevent problems in the future, ultimately improving care for others. However, like all research, there might be some risks. While genetic testing generally carries very few direct physical risks, there could be emotional considerations related to learning more about individual genetic information, though the summary doesn't specify if individual results will be shared. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Verified postcode
Düsseldorf, Germany

Common questions

What is the main goal of this study?

The main goal is to understand why some heart transplant patients develop heart problems later on, by looking at how their genes and lifestyle factors work together.

Who can take part in this study?

Adults (aged 18 or older) who have had a heart transplant at the study's hospital and are able to give their consent to participate are eligible.

What kind of tests will be done?

The study involves a variety of health measurements, such as heart scans, exercise tests, and detailed genetic tests, including a new type of gene sequencing.

Will I get to see my genetic test results?

The information provided does not specify whether individual genetic test results will be shared with participants. It's best to discuss this directly with the study team.

Is my medical care affected if I don't join?

No, your decision to participate or not will not affect the quality of your medical care in any way.

How to find out more

Daniel Oehler, MD

daniel.oehler@med.uni-duesseldorf.de +492118118800 Official trial record

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