The SMARTER Cardiomyopathy Study

Cardiomyopathies Clinical Trial

— SMARTER-CM  

Official title:

Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750147
• Other study ID #: 22IC7783
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Study Coordinator
• Phone: 02073528121
• Email: smarter-cm[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy

Intervention

Other:
• Blood Sample Collection
Blood for DNA and biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Guys & St Thomas' NHS Foundation Trust	London
United Kingdom	Kings College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of genetic variants	Rare and common genetic variants in people with cardiomyopathy	5 years
Primary	The incidence of major adverse cardiovascular events over 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)	5 years