Clinical trial NCT06836011: A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
Official title: Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ATTR Amyloidosis With Cardiomyopathy
ATTR-CM
ATTR Amyloidosis Wild Type
Mitral Regurgitation
Tricuspid Regurgitation
Keywords: ATTR-CM
ATTR amyloidosis
Tricuspid Regurgitation
Mitral Regurgitation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: up to 60 months
Secondary outcomes:
measure: Cardiovscular mortality
timeFrame: up to 60 months
measure: Heart Failure Hospitalization
timeFrame: up to 60 months
Other outcomes:
measure: Progression of Atrioventricular Regurgitation
timeFrame: At 12 and 24 months follow-up
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
city: Vienna
country: Austria
facility: Department of Internal Medicine II, Medical University of Vienna
city: Munich
country: Germany
facility: Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Department of Cardiology, University Hospital Frankfurt, Goethe University
state: Hessen
city: Brescia
country: Italy
facility: Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
city: Ferrara
country: Italy
facility: Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
city: Trieste
country: Italy
facility: Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: 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.