Understanding genetics and outcomes in patients with Dilated Cardiomyopathy
Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy: a Prospective Multi-centre Observational Study
Imperial College London · NCT03843255
This study is trying to understand how genetics affect heart function in people with Dilated Cardiomyopathy to help create better, personalized treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 99 Years |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 6 sites (Leeds and 5 other locations) |
| Trial ID | NCT03843255 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis and treatment of Dilated Cardiomyopathy (DCM) by recruiting patients from various hospitals across England. Participants will undergo whole genome sequencing and cardiovascular magnetic resonance imaging (MRI) to identify genetic changes and heart function alterations. The study will follow patients over several years, collecting health information and quality of life data through questionnaires and national registries. The goal is to develop tailored treatments based on genetic and clinical findings.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age with a confirmed diagnosis of Dilated Cardiomyopathy and their affected family members.
Not a fit: Patients whose DCM is attributed to chemotoxicity or systemic inflammatory myopathies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and personalized treatment options for patients with Dilated Cardiomyopathy.
How similar studies have performed: Other studies have shown promise in using genetic testing and imaging techniques for cardiovascular diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
PART 1 Inclusion Criteria: * Male or female participants of any age * Capacity to provide informed consent * Patients with a confirmed diagnosis of DCM * Affected family members of patients meeting diagnostic criteria for DCM Exclusion Criteria: * DCM attributed to chemotoxicity (from chemotherapeutic agents, drugs of abuse) * DCM attributed to systemic inflammatory myopathies (eg sarcoid, systemic lupus erythematosus) * Patients who lack capacity to consent for themselves * Patients with a confirmed history of coronary artery disease, assessed using standard UK clinical practice guidelines, defined as one or more of the following:- * \>50% narrowing, any major epicardial coronary artery on invasive or computed tomography coronary angiography * CMR suggestive of previous myocardial infarction of ≥2 segments of ≥50% infarction of the LV wall * Previous percutaneous coronary intervention or coronary bypass surgery * History of primary valvular heart disease or congenital heart disease * Severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm Hg and/or diastolic blood pressures \>120 mm Hg) PART 2 Inclusion Criteria: * Males or females of any age * Capacity to provide informed consent * Patients with hypokinetic non-dilated cardiomyopathy, or * Family members of DCM patients with possible or probable DCM or * Patients with a confirmed diagnosis of heritable cardiovascular disease or * Family members of patients with heritable cardiovascular disease, both affected and unaffected Exclusion Criteria: * Patients who lack capacity to consent for themselves * Patients with a confirmed history of coronary artery disease, assessed using standard UK clinical practice guidelines, defined as one or more of the following:- * \>50% narrowing, any major epicardial coronary artery on invasive or computed tomography coronary angiography * CMR suggestive of previous myocardial infarction of ≥2 segments of ≥50% infarction of the LV wall * Previous percutaneous coronary intervention or coronary bypass surgery * History of primary valvular heart disease or congenital heart disease * Severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm Hg and/or diastolic blood pressures \>120 mm Hg)
Where this trial is running
Leeds and 5 other locations
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (RECRUITING)
- Glenfield Hospital — Leicester, United Kingdom (RECRUITING)
- Liverpool Heart and Chest Hospital NHS Foundation Trust — Liverpool, United Kingdom (RECRUITING)
- Royal Brompton & Harefield NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (RECRUITING)
- Southampton General Hospital — Southampton, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: James Ware — Imperial College London
- Study coordinator: James Ware
- Email: go-dcm@imperial.ac.uk
- Phone: 0330 128 2294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dilated Cardiomyopathy, Cardiovascular Diseases