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

NCT ID: NCT06836011

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christian Nitsche

Priv.-Doz. Dr. med. univ., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Graz

Graz, Styria, Austria

Site Status RECRUITING

Department of Internal Medicine II, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

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

Munich, Bavaria, Germany

Site Status RECRUITING

Department of Cardiology, University Hospital Frankfurt, Goethe University

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

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

Brescia, , Italy

Site Status RECRUITING

Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara

Ferrara, , Italy

Site Status RECRUITING

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

Trieste, , Italy

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany Italy Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

+4314040048590

Laurenz Hauptmann, Dr.

Role: CONTACT

+4314040048590

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicolas D Verheyen, Res.Prof. Priv.-Doz. DDr.

Role: primary

+43 (0)316 385 30173

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

Role: primary

+4314040048590

Stephanie Bieber, Dr. med.

Role: primary

Maria Papathanasiou, Priv.-Doz. Dr. med.

Role: primary

+496963017387

Marianna Adamo, Assoc.-Prof. Dr.

Role: primary

Matteo Serenelli, Dr.

Role: primary

Marco Merlo, Prof. Dr.

Role: primary

+39 040 3994875

Marish I.F.J. Oerlemans, Ass. Prof. Dr.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36008266 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATTR-CM-AVR-2025-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tricuspid Regurgitation in the ElderlY
NCT05784883 ACTIVE_NOT_RECRUITING