NCT03843255|Active Not Recruiting
Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy
Go-DCM
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Go-DCM
Sponsor study identifier
observational
2,000
1 country
6
Study Start
January 9, 2020
Actual (reported)Primary Completion
July 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 16, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Finding new ways to diagnose and treat Dilated Cardiomyopathy (DCM) could improve the health and well-being of patients with this condition. The main aim of this research study is to help develop better ways of diagnosing and treating patients with DCM. The information that is collected may help develop tailored treatments for patients with this disease in the future. This research study will recruit patients with DCM from a number of centres across England and follow their health over a period of years. Patients will give some blood samples for a type of genetic test called whole genome sequencing (WGS) to look for genetic changes. Patients will also have a magnetic resonance imaging (MRI) scan of their heart to look for any changes in the heart such as scarring, and check their heart function. The aim of this study is to discover if using WGS and MRI can improve the diagnosis of DCM. Another aim of the study is to look at how genetic changes and scarring in the heart may affect the progress of the disease. Studying patients with DCM may also help the investigators learn more about diagnosing and treating other diseases of the heart. The second aim of this study is to see whether using WGS and MRI scanning can also be useful in other types of heart diseases which might be affected by genetic changes or scarring in the heart.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2019
Actual (reported)February 18, 2019
Actual (reported)January 9, 2020
Actual (reported)July 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 16, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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) We will recruit a group of patients that could be asked to take part in future research projects to evaluate personalised treatments for DCM and other cardiovascular diseases.
5 years
Incidence of novel gene variants as assessed using whole genome sequencing
Identifying the gene variants contributing to DCM and specifically the incidence of these variants in the target population.
5 years
Approximately 1200 patients recruited prospectively from participating sites with a diagnosis of Dilated Cardiomyopathy (DCM). Will also include approximately 800 retrospective patients diagnosed with DCM currently biobanked by the lead site.
Patients may be recruited with other diagnosed heritable cardiovascular disorders. Family members of patients may be invited to take part in the study. Children may also be approached to take part in the study.
Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
Biomarker analysis will be undertaken on samples
* Patients of any age with diagnosed DCM (part 1), and * Their family members with other heritable cardiovasacular disease (affected and unaffected), or other eligible patients with hypokinetic non-dilated cardiomyopathy (part 2)
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, SW3 6NP, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
1. Blood- plasma and serum 2. Saliva 3. Collection of additional tissue samples (myocardial, skeletal, skin) from planned clinical procedures (where applicable)
James Ware
Imperial College London
First Submitted
January 31, 2019
First Posted
February 18, 2019
Study Start
January 9, 2020
Actual (reported)Primary Completion
July 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Inter-field Strength Agreement of CMR Derived Strain
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Study Completion
June 16, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 27, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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