The SMARTER Cardiomyopathy Study

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.

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Key information

Conditions

Cardiomyopathies Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Laminopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

Blood for DNA and biomarker analysis

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:-
- 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

02073528121

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy

Acronym: SMARTER-CM

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Mar 1, 2023
Registry last updated: Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting