What is this study trying to find out about transthyretin amyloid cardiomyopathy (ATTR-CM)?

This study is investigating how common mitral and tricuspid valve leakage is in patients with ATTR-CM, and how the severity of this leakage relates to patient outcomes. The goal is to develop better ways to measure valve leakage specific to the heart changes in ATTR-CM. The Medical University of Vienna is leading this research to improve understanding of this condition.

Who may be eligible for this ATTR-CM clinical trial?

Adults aged 18 years or older diagnosed with transthyretin amyloid cardiomyopathy and who have had recent detailed heart ultrasound assessments may be eligible. Both men and women can participate. Those with severe aortic valve disease needing intervention or who cannot provide informed consent are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ATTR-CM clinical trial?

Study-related care, including all study visits and assessments, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Age: 18Years +

All Genders

ID06836011

Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study

Led by Medical University of Vienna · Updated on 2025-02-19

600

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to better understand mitral and tricuspid valve leakage regurgitation in patients diagnosed with transthyretin amyloid cardiomyopathy ATTR-CM. It focuses on measuring how common these valve problems are, their severity, and how they affect patient outcomes. The study also seeks to create new standards for grading this leakage that fit the unique heart function changes seen in ATTR-CM, improving on current methods that do not account for this specific condition. As an observational study, it will gather detailed heart ultrasound echocardiographic data from patients with ATTR-CM, focusing on quantitative and semi-quantitative measures of mitral and tricuspid regurgitation. There are no experimental treatments instead, the study collects information to better define and predict the impact of valve leakage in this condition. The research is conducted internationally across multiple centers, starting in 2025. Participants will undergo comprehensive baseline heart ultrasound assessments within about six months of diagnosis and then be followed for up to 60 months. Researchers will track outcomes including all-cause death, cardiovascular death, and hospitalizations due to heart failure. The study involves regular clinical follow-up and data collection to analyze the relationship between valve leakage measures and patient prognosis under typical care conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of ATTR-CM according to current diagnostic criteria
Comprehensive baseline echocardiographic assessment including (semi-)quantitative mitral and tricuspid regurgitation parameters performed within ±6 months of diagnosis
Age 18 years or older
Willingness to participate in the study and provide informed consent

You will not qualify if you...

Severe aortic valve disease requiring intervention
Inability to provide informed consent or participate in study follow-up

Research Team

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

Laurenz Hauptmann, Dr.

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