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

February 14, 2025 updated by: Christian Nitsche, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Internal Medicine II, Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Christian Nitsche, Priv.-Doz. Dr., PhD
        • Sub-Investigator:
          • Laurenz Hauptmann, Dr.
    • Styria
      • Graz, Styria, Austria, 8010
        • Recruiting
        • Medical University of Graz
        • Contact:
        • Principal Investigator:
          • Nicolas D Verheyen, Res.Prof. Priv.-Doz. DDr.
  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81377
        • Recruiting
        • Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
        • Contact:
        • Principal Investigator:
          • Stephanie Bieber, Dr. med.
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60596
        • Recruiting
        • Department of Cardiology, University Hospital Frankfurt, Goethe University
        • Contact:
        • Principal Investigator:
          • Maria Papathanasiou, Priv.-Doz. Dr. med.
  • Italy
      • Brescia, Italy, 25100
        • Recruiting
        • Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
        • Contact:
        • Principal Investigator:
          • Marianna Adamo, Assoc.-Prof. Dr.
      • Ferrara, Italy, 44121
        • Recruiting
        • Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
        • Contact:
        • Principal Investigator:
          • Matteo Serenelli, Dr.
      • Trieste, Italy, 34100
        • Recruiting
        • Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
        • Contact:
        • Principal Investigator:
          • Marco Merlo, Prof. Dr.
  • Netherlands
      • Utrecht, Netherlands, 3450
        • Recruiting
        • University Medical Center Utrecht
        • Contact:
        • Principal Investigator:
          • Marish I.F.J. Oerlemans, Ass. Prof. Dr.
        • Sub-Investigator:
          • Steven A Muller, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovscular mortality
Time Frame: up to 60 months
up to 60 months
Heart Failure Hospitalization
Time Frame: up to 60 months
Time to first heart failure hospitalization Rate of heart failure hospitalizations
up to 60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 and 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATTR-CM-AVR-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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