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NCT Number: NCT06836011

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

The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.

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Key information

Conditions

ATTR Amyloidosis With Cardiomyopathy ATTR Amyloidosis Wild Type ATTR-CM Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency Tricuspid Regurgitation Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Styria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: up to 60 months

    Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity

Secondary outcomes

  1. Cardiovscular mortality

    Time frame: up to 60 months

  2. Heart Failure Hospitalization

    Time frame: up to 60 months

    Time to first heart failure hospitalization Rate of heart failure hospitalizations

Other outcomes

  1. Progression of Atrioventricular Regurgitation

    Time frame: At 12 and 24 months follow-up

    Change in mitral and tricuspid regurgitation severity over time and its impact on clinical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+4314040048590

Laurenz Hauptmann, Dr.

CONTACT

[email protected]

+4314040048590

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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