The SMARTER Cardiomyopathy Study

NCT05750147 | Recruiting

• 1 other identifier: 22IC7783
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiomyopathies; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Incidence of genetic variants

  Rare and common genetic variants in people with cardiomyopathy

  5 years

• The incidence of major adverse cardiovascular events over 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)

  5 years

Study Arms (1)

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

Interventions

Blood Sample Collection OTHER

Blood for DNA and biomarker analysis

Cardiomyopathies

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with a diagnosis of cardiomyopathy, or a family member of cardiomyopathy or a genetic predisposition to cardiomyopathy of any age and any sex.

You may qualify if:

• 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

You may not qualify if:

• Patients without the capacity to provide informed consent

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Guys & St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Kings College Hospital

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood- plasma and serum 2. Saliva 3. Collection of additional tissue samples (myocardial, skeletal, skin) or excess diagnostic materials from planned clinical procedures (where applicable)

MeSH Terms

Conditions

Cardiomyopathies; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• James Ware

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

02073528121; smarter-cm@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: March 1, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During study duration (Aug 2027)
• Access Criteria: Provided through secure data transfer mechanisms approved by Imperial College London, following full GDPR (data protection) assessments and collaborating agreements.

Locations

GB (2)