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Clinical Trials/NCT05750147
NCT05750147
Recruiting
Not Applicable

Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy

Imperial College London2 sites in 1 country1,000 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathies
Sponsor
Imperial College London
Enrollment
1000
Locations
2
Primary Endpoint
Incidence of genetic variants
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses.

Finding new ways to diagnose and treat cardiomyopathies could improve the health and well-being of patients with these conditions.

This study will collect data from individuals with cardiomyopathy or related heart muscle disease, or with a possible genetic predisposition to cardiomyopathy, and follow them over time to observe the progress of their heart and health. This study will collect DNA, blood samples, and detailed clinical & lifestyle information at the start of the study, and data collected during routine healthcare visits over time.

  • learn what causes cardiomyopathy, and therefore how to treat it
  • understand why cardiomyopathy progresses differently in different people, to improve the ability to recognise who will benefit from different treatments at different times

The investigators will collaborate with other centres internationally to collect a large of group of participants with similar cardiomyopathies, providing power to identify new pathways that cause disease and ways of predicting which participants are at risk of having more severe disease.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
August 1, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults with the capacity to consent Children with parental/guardian consent Male and Female
  • Meeting the following criteria:
  • Patients with a confirmed diagnosis of cardiomyopathy or related condition
  • Patients with a family member with cardiomyopathy, or a related condition
  • Patients with a genetic variant that may predispose to cardiomyopathy, or a related condition

Exclusion Criteria

  • Patients without the capacity to provide informed consent

Outcomes

Primary Outcomes

Incidence of genetic variants

Time Frame: 5 years

Rare and common genetic variants in people with cardiomyopathy

The incidence of major adverse cardiovascular events over 5 years

Time Frame: 5 years

The incidence of major adverse cardiovascular events over 5 years, defined as:- 1. Cardiovascular death 2. Major arrhythmic events (ventricular fibrillation, unstable sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator delivered shock, and aborted sudden cardiac death) 3. Major heart failure events (heart transplantation, left ventricular assist device implantation, unplanned heart failure hospitalisation)

Study Sites (2)

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