Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy (Go-DCM)
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|ClinicalTrials.gov Identifier: NCT03843255|
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
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.
|Condition or disease||Intervention/treatment|
|Dilated Cardiomyopathy Cardiovascular Diseases||Other: Part 1: DCM Cohort Other: Part 2: Heritable CV Diseases and Family Members|
This study will recruit patients from a number of hospitals in England and study them over a number of years. The study will be divided in 2 parts. Part 1 will recruit patients with a diagnosis of DCM, Part 2 will recruit patients diagnosed with other 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 will attend for a baseline visit for a cardiovascular magnetic resonance (CMR) scan, completion of quality of life questionnaires, collection of blood samples for whole genome sequencing and biomarker analysis, and collection of clinical data. Collection of health information via national registries including Office of National Statistics (ONS) and Hospital Episodes Statistics (HES) will be continued over the patients's lifetime. This will not require any direct contact with the participant.
Recruitment will take place over a 3 year period, with annual completion of questionnaires at patients scheduled hospital visits. If the patient is not scheduled to attend the hospital for regular follow up, then patients may complete the questionnaires via an online system or over the telephone. Patients will be asked to complete questionnaires annually for 5 years. Sub-sets of patients may be invited for additional tests including exercise testing, and stress perfusion scans. These tests will not form part of the core tests for the study, and patients may choose not to have them. Separate informed consent will be obtained from participants for any additional tests.
If patients are having clinical diagnostic tests that involve the removal of tissue, they may be asked to donate any surplus tissue sample, or be asked to provide their consent to collect an additional tissue sample. Separate informed consent will be obtained from participants for donation of additional tissue samples.
Where patients are scheduled to have a CMR scan as part of their routine clinical care, an additional CMR scan for research purposes may not be required.
Children will not be asked to complete any annual questionnaires, health information will be collected via ONS and HES.
Family members of patients who take part in the study will only be asked to donate a blood or saliva sample, and provide consent to collection of their health information via ONS and HES records. They will not have any clinical tests such as CMR.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy: a Prospective Multi-centre Observational Study|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||December 16, 2022|
|Estimated Study Completion Date :||December 16, 2022|
Part 1: Dilated Cardiomyopathy patients
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.
Other: Part 1: DCM Cohort
Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
Other Name: Whole genome sequencing and biomarker analysis
Part 2: Heritable Cardiovascular Disease
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.
Other: Part 2: Heritable CV Diseases and Family Members
Biomarker analysis will be undertaken on samples
Other Name: Biomarker analysis
- 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) 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.
- Incidence of novel gene variants as assessed using whole genome sequencing [ Time Frame: 5 years ]Identifying the gene variants contributing to DCM and specifically the incidence of these variants in the target population.
Biospecimen Retention: Samples With DNA
- Blood- plasma and serum
- Collection of additional tissue samples (myocardial, skeletal, skin) from planned clinical procedures (where applicable)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843255
|Contact: Sarah Chopping||0330 128 firstname.lastname@example.org|
|Contact: Chief Investigator||0330 128 email@example.com|
|Principal Investigator:||James Ware||Imperial College London|