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

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Department of Internal Medicine II, Medical University of Vienna
RECRUITING
Vienna
Germany
Department of Cardiology, University Hospital Frankfurt, Goethe University
RECRUITING
Frankfurt Am Main
Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
RECRUITING
Munich
Italy
Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
RECRUITING
Brescia
Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
RECRUITING
Ferrara
Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
RECRUITING
Trieste
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Christian Nitsche, Priv.-Doz. Dr., PhD
christian.nitsche@meduniwien.ac.at
+4314040048590
Backup
Laurenz Hauptmann, Dr.
Laurenz.hauptmann@meduniwien.ac.at
+4314040048590
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov