SMARTER-CM: The SMARTER Cardiomyopathy Study

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05750147
Collaborator
(none)
1,000
53

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Sample Collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Cardiomyopathies

Approximately 1000 participants recruited prospectively from participating sites with a diagnosis of cardiomyopathy Participants will provide biosamples and allow access to medical scans and records for health data collection

Other: Blood Sample Collection
Blood for DNA and biomarker analysis

Outcome Measures

Primary Outcome Measures

  1. Incidence of genetic variants [5 years]

    Rare and common genetic variants in people with cardiomyopathy

  2. The incidence of major adverse cardiovascular events over 5 years [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Adults with the capacity to consent Children with parental/guardian consent Male and Female

Meeting the following criteria:
  1. Patients with a confirmed diagnosis of cardiomyopathy or related condition

  2. Patients with a family member with cardiomyopathy, or a related condition

  3. Patients with a genetic variant that may predispose to cardiomyopathy, or a related condition

Exclusion Criteria:

Patients without the capacity to provide informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: James Ware, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05750147
Other Study ID Numbers:
  • 22IC7783
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023