The SMARTER Cardiomyopathy Study

Recruiting

• Conditions: Cardiomyopathies; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy
• Interventions: Other: Blood Sample Collection

• Registration Number: NCT05750147
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-20
• Study Start: 2023-03-01
• Study First Posted: 2023-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiomyopathies	Blood Sample Collection	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

Primary Outcome Measures

Name	Time	Method
Incidence of genetic variants	5 years	Rare and common genetic variants in people with cardiomyopathy
The incidence of major adverse cardiovascular events over 5 years	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)

Trial Locations

Locations (2)

Kings College Hospital; 🇬🇧 London, United Kingdom

Guys & St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom