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

NCT06836011 | Recruiting

• 1 other identifier: ATTR-CM-AVR-2025-001
• Study Type: observational
• Target: 600
• Locations: 4 countries
• Sites: 8

Brief Summary

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.

Conditions

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

Keywords

ATTR-CM; ATTR amyloidosis; Tricuspid Regurgitation; Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

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

  up to 60 months

Secondary Outcomes (2)

• Cardiovscular mortality

  up to 60 months

• Heart Failure Hospitalization

  up to 60 months

Other Outcomes (1)

• Progression of Atrioventricular Regurgitation

  At 12 and 24 months follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational study will include patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) from international specialized cardiac amyloidosis referral centers. The study population will encompass both wild-type and hereditary ATTR-CM patients, ensuring representation of diverse disease phenotypes. Data collection will be standardized across centers, with echocardiographic assessments performed in accordance with the dedicated study protocol. The inclusion of multiple international centers will enhance the generalizability of findings across different healthcare systems and patient populations.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (8)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

Department of Internal Medicine II, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University

Munich, Bavaria, 81377, Germany

RECRUITING

Department of Cardiology, University Hospital Frankfurt, Goethe University

Frankfurt am Main, Hesse, 60596, Germany

RECRUITING

Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia

Brescia, 25100, Italy

RECRUITING

Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44121, Italy

RECRUITING

Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste

Trieste, 34100, Italy

RECRUITING

University Medical Center Utrecht

Utrecht, 3450, Netherlands

RECRUITING

Related Publications (1)

• Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.

  PMID: 36008266 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

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

CONTACT

+4314040048590; christian.nitsche@meduniwien.ac.at

Laurenz Hauptmann, Dr.

CONTACT

+4314040048590; Laurenz.hauptmann@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med. univ., PhD

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

AU (2); IT (3); DE (2); NL (1)