Active not recruitingNAINTERVENTIONAL

TRICuspid Intervention in Heart Failure Trial

This study, called TRICuspid Intervention in Heart Failure Trial (TRIC-I-HF-DZHK24), aims to understand if a special kind of heart valve treatment, called transcatheter tricuspid valve treatment (TTVT), can help patients with severe tricuspid regurgitation and heart failure. This condition means a valve in the heart doesn't close properly, leading to symptoms like breathlessness. While TTVT has been shown to improve how people feel, doctors still don't know if it can reduce hospital stays for heart failure or help people live longer. This study will compare TTVT plus standard medical care against standard medical care alone in about 360 patients who are at higher risk of heart failure hospitalisation. It hopes to show if TTVT is a better strategy for these patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

LMU Klinikum

Enrolment target

360

Start

25 Mar 2022

Estimated completion

01 Oct 2028

Heart Failure Attributable to Severe Tricuspid Regurgitation

What is this study about?

The TRICuspid Intervention in Heart Failure Trial (TRIC-I-HF-DZHK24) is designed to help doctors understand the best way to treat a specific heart problem called severe tricuspid regurgitation, especially in people who also have heart failure. Tricuspid regurgitation happens when the tricuspid valve in your heart doesn't close tightly enough, causing blood to leak backward. This can make the heart work harder and lead to symptoms of heart failure, like feeling tired or breathless. While treatments for this valve problem have shown promise in making people feel better, we don't yet know if they can truly help people stay out of the hospital or live longer.

This study is looking at a treatment called transcatheter tricuspid valve treatment (TTVT). This is a less invasive procedure than open-heart surgery, where doctors use a thin tube (catheter) to fix or repair the valve without making large cuts. The study will compare patients who receive TTVT along with their usual medications, to those who only receive their usual medications. Researchers will be looking to see if TTVT can reduce the number of times people need to be hospitalised for heart failure and improve their overall health and quality of life. This research is important because it focuses on patients who are at a higher risk of heart problems, aiming to find better ways to help them.

The study involves about 360 patients across 29 medical centres in Germany. Patients will be followed for three years, with the main results being checked after one year. The aim is to gather strong evidence to guide doctors on when and for whom this transcatheter valve treatment is most beneficial, particularly in those most affected by heart failure.

Key takeaways

This study investigates a new, less invasive heart valve treatment for severe leaky tricuspid valves.
It focuses on patients with heart failure who are at higher risk of hospitalisation.
The study compares the new treatment plus usual care against usual care alone.
The main goals are to see if the treatment reduces hospital stays and improves quality of life.
Participation involves strict eligibility checks and close monitoring over three years.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and experiencing symptoms from severe tricuspid regurgitation, even though you’re already on stable medications for at least a month. A key part of eligibility is that you should also be at a higher risk of heart problems. This means you would have been in the hospital for heart failure in the last year, or have specific kidney or liver problems related to your heart condition.

There are also some reasons why you might not be able to join. For example, if you have other significant heart valve problems, or if you’ve had a heart attack or stroke recently (in the last 3 months). Also, if your heart valve anatomy isn't suitable for the procedure, or if you have certain pacemakers that would get in the way, you wouldn't be able to participate. Doctors will check all these details carefully to make sure the study is safe and appropriate for you.

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 or older?
Do you have severe tricuspid regurgitation with symptoms, despite stable medication?
Have you been hospitalised for heart failure in the last year, OR do you have heart-related kidney or liver problems?
Are your heart valves generally suitable for this type of repair?
Do you have a life expectancy of more than 12 months?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive either the special transcatheter tricuspid valve treatment (TTVT) alongside your usual medications, or just your usual medications. The decision on which treatment you receive will be made randomly, like flipping a coin. If you receive TTVT, the doctors will use the best suitable device for your individual heart valve problem, chosen by a team of heart specialists. Throughout the study, you would have regular visits to the hospital for checks and assessments, including heart scans, to see how you are responding to treatment. You will be followed closely for a total of three years to monitor your health and any potential complications, with key assessments happening at the one-year mark.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from a new treatment not yet widely available, and you'll receive careful monitoring of your health. However, any medical procedure has risks, and TTVT may include risks like bleeding, infection, or complications related to the heart procedure itself. It's also possible the treatment might not work for you, or you could experience side effects. The study also helps expand medical knowledge, which could benefit others in the future. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Herz- und Diabeteszentrum Nordrhein-Westfalen
Verified postcode
Bad Oeynhausen, Germany
Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
Deutsches Herzzentrum Berlin
Verified postcode
Berlin, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Verified postcode
Bernau, Germany
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany
Herzzentrum Bremen
Verified postcode
Bremen, Germany
Herzzentrum Uniklinik Köln
Verified postcode
Cologne, Germany
St.-Johannes-Hospital Dortmund
Verified postcode
Dortmund, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
Helios Klinikum Erfurt
Verified postcode
Erfurt, Germany
Universitätsklinikum Essen
Verified postcode
Essen, Germany
Universitätsklinikum Frankfurt
Verified postcode
Frankfurt, Germany

Common questions

What is tricuspid regurgitation?

It's a heart problem where one of your heart valves, called the tricuspid valve, doesn't close properly, causing blood to leak backwards in your heart.

What is transcatheter tricuspid valve treatment (TTVT)?

It's a way to fix the leaky tricuspid valve using a thin tube inserted into a blood vessel, rather than open-heart surgery, to repair or replace the valve.

Why is this study being done?

Doctors want to find out if TTVT, combined with usual care, can help people with severe tricuspid regurgitation and heart failure live longer and stay out of the hospital, compared to just usual care.

Will I know which treatment I'm getting?

This study is 'open-label', meaning both you and your doctor will know if you are receiving the TTVT or only standard medical care.

How long will I be in the study?

You will be followed by the study team for a total of three years to monitor your health and treatment results.