Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair.
Carolina Donà, Christian Nitsche, Matthias Koschutnik...
https://pubmed.ncbi.nlm.nih.gov/36008266Actively Recruiting
Age: 18Years +
All Genders
ID06836011
Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
Led by Medical University of Vienna · Updated on 2025-02-19
600
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand mitral and tricuspid valve leakage (regurgitation) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). It focuses on measuring how common these valve problems are, their severity, and how they affect patient outcomes. The study also seeks to create new standards for grading this leakage that fit the unique heart function changes seen in ATTR-CM, improving on current methods that do not account for this specific condition. As an observational study, it will gather detailed heart ultrasound (echocardiographic) data from patients with ATTR-CM, focusing on quantitative and semi-quantitative measures of mitral and tricuspid regurgitation. There are no experimental treatments; instead, the study collects information to better define and predict the impact of valve leakage in this condition. The research is conducted internationally across multiple centers, starting in 2025. Participants will undergo comprehensive baseline heart ultrasound assessments within about six months of diagnosis and then be followed for up to 60 months. Researchers will track outcomes including all-cause death, cardiovascular death, and hospitalizations due to heart failure. The study involves regular clinical follow-up and data collection to analyze the relationship between valve leakage measures and patient prognosis under typical care conditions.
CONDITIONS
Brief Title
A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of ATTR-CM according to current diagnostic criteria
- Comprehensive baseline echocardiographic assessment including (semi-)quantitative mitral and tricuspid regurgitation parameters performed within ±6 months of diagnosis
- Age 18 years or older
- Willingness to participate in the study and provide informed consent
You will not qualify if you...
- Severe aortic valve disease requiring intervention
- Inability to provide informed consent or participate in study follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within ±6 months of diagnosis
Participants undergo comprehensive baseline echocardiographic assessment including mitral and tricuspid regurgitation parameters.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants are monitored for all-cause and cardiovascular mortality, and heart failure hospitalization over time.
Regular follow-up visits during monitoring period
Trial Site Locations
Total: 8 locations
1
Medical University of Graz
Graz, Styria, Austria, 8010
Actively Recruiting
2
Department of Internal Medicine II, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
3
Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
Munich, Bavaria, Germany, 81377
Actively Recruiting
4
Department of Cardiology, University Hospital Frankfurt, Goethe University
Frankfurt am Main, Hesse, Germany, 60596
Actively Recruiting
5
Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
Brescia, Italy, 25100
Actively Recruiting
6
Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy, 44121
Actively Recruiting
7
Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
Trieste, Italy, 34100
Actively Recruiting
8
University Medical Center Utrecht
Utrecht, Netherlands, 3450
Actively Recruiting
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Research Team
C
Christian Nitsche, Priv.-Doz. Dr., PhD
L
Laurenz Hauptmann, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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