RecruitingOBSERVATIONAL

A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.

This study focuses on a specific heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In this condition, abnormal proteins build up in the heart, making it stiff. Researchers are studying how often and how severely two important heart valves, the mitral and tricuspid valves, leak (a problem called regurgitation) in people with ATTR-CM. They want to understand if this leakage is more common or different in ATTR-CM patients compared to others, and how it affects their health over time. The goal is to create better ways to measure this leakage, which could lead to earlier and more accurate diagnosis and improved treatment plans for people with ATTR-CM.

At a glance

Status

Recruiting

Sponsor

Medical University of Vienna

Enrolment target

600

Start

01 Jan 2025

Estimated completion

31 Dec 2026

ATTR Amyloidosis With Cardiomyopathy ATTR-CM ATTR Amyloidosis Wild Type Mitral Regurgitation Tricuspid Regurgitation

What is this study about?

This study is about a heart condition called transthyretin amyloid cardiomyopathy, often shortened to ATTR-CM. In ATTR-CM, a protein called transthyretin builds up in the heart. This makes the heart muscle stiff and unable to pump blood as effectively as it should. Many people with heart conditions can also have problems with their heart valves, which are like small gates that control blood flow.

Specifically, this research is looking at two particular heart valves: the mitral valve and the tricuspid valve. Sometimes, these valves don't close properly, causing blood to leak backward. This is called regurgitation. The doctors want to find out how often this leakage happens in people with ATTR-CM, how severe it usually is, and how it might affect their health and how they feel over time.

The main aim is to get a clearer picture of this valve leakage problem in ATTR-CM patients. They also want to develop better, more accurate ways to measure how severe the leakage is. This is important because the way these valves work in ATTR-CM might be different from other heart conditions. By understanding this better, doctors hope to improve how ATTR-CM is diagnosed and treated in the future, ultimately leading to better health for patients.

Key takeaways

The study focuses on heart valve leakage in ATTR-CM patients.
It aims to understand how common and severe this leakage is.
Researchers hope to create better ways to measure valve problems.
The findings could lead to improved diagnosis and treatment for ATTR-CM.
This is an 'observational' study, using existing medical information.
Participation involves no new treatments or extra procedures.

Who may be eligible?

This study is looking for adults aged 18 or older who have already been diagnosed with a specific heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). To join, your doctors would need to have already checked your heart carefully using a scan called an echocardiogram, preferably around the time of your diagnosis, to look at your heart valves.

It's important that you are willing to take part in the study and are able to formally agree to do so. This means understanding what the study involves and signing a consent form.

You wouldn't be able to join if you have a severe problem with another heart valve called the aortic valve that needs an operation. Also, if for any reason you can't understand the study or follow its instructions, you wouldn't be able to participate.

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.

I am 18 years old or older.
I have been diagnosed with ATTR-CM.
I have recently had a heart scan (echocardiogram) that looked at my heart valves.
I do not have a severe problem with my aortic heart valve that needs surgery.
I am able to understand and agree to take part in a study.

Answer every question to see your result.

What does participation involve?

This study is a ‘registry study’, which means it primarily involves collecting and looking at information that doctors already gather during a patient's routine care. You wouldn't be asked to take any new medications just for this study. The main part of participating would involve allowing the researchers to use information from your existing medical records, especially details from your heart scans (echocardiograms).

The study would involve reviewing your medical history, particularly information about your ATTR-CM diagnosis and any heart valve issues. Researchers would also collect information on your health and how you are doing over time. You wouldn't need extra visits or assessments beyond your usual medical appointments. The total duration of your participation would depend on how long the researchers choose to follow your health information after you join.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gathered could help doctors better understand ATTR-CM and improve care for future patients. There are no direct medical risks as you wouldn't receive new treatments or undergo extra procedures for the study. However, as with any research, there's always a small chance that your information could become known, though strict steps are taken to protect your privacy. Remember, you can decide to stop participating at any time without it affecting your usual medical care.

Locations (8)

Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
Department of Internal Medicine II, Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
Verified postcode
Munich, Germany· Recruiting
Department of Cardiology, University Hospital Frankfurt, Goethe University
Verified postcode
Frankfurt am Main, Germany· Recruiting
Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
Verified postcode
Brescia, Italy· Recruiting
Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
Verified postcode
Ferrara, Italy· Recruiting
Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
Verified postcode
Trieste, Italy· Recruiting
University Medical Center Utrecht
Verified postcode
Utrecht, Netherlands· Recruiting

Common questions

What is ATTR-CM?

ATTR-CM is a heart condition where special proteins build up and make the heart stiff, making it harder to pump blood.

What does 'regurgitation' mean?

Regurgitation means that one of your heart valves isn't closing properly, letting some blood leak backward instead of flowing forward.

Will I get any new treatments in this study?

No, this study is about collecting information from your existing medical records; you won't get new treatments or medications.

How long will I be in the study?

You won't have extra visits. The researchers will follow your health information over a period of time, using your existing medical notes.

Who can join this study?

Adults (18+) already diagnosed with ATTR-CM who have had specific heart scans may be able to join.

How to find out more

Christian Nitsche, Priv.-Doz. Dr., PhD

christian.nitsche@meduniwien.ac.at +4314040048590 Official trial record

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