Dilated CardiomyopathyGo-DCMNCT03843255
Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy and Cardiovascular Diseases, run by Imperial College London at 6 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Dilated Cardiomyopathy, Cardiovascular Diseases
- What is being tested?
- Part 1: DCM Cohort and Part 2: Heritable CV Diseases and Family Members
- How many people
- 2,000 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 9 Jan 2020to 16 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * 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)
Who may be able to join
- 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
- Males or females of any age
- Capacity to provide informed consent
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- 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
Who cannot join
- 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
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- 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
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
Glenfield Hospital
Leicester, LE3 9QP
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
Royal Brompton & Harefield NHS Foundation Trust
London, SW3 6NP
Oxford University Hospitals NHS Foundation Trust
Oxford
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy: a Prospective Multi-centre Observational Study
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.
Read the detailed description
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.
- Conditions
- Dilated Cardiomyopathy, Cardiovascular Diseases
- Being tested
- Part 1: DCM Cohort, Part 2: Heritable CV Diseases and Family Members
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1: DCM CohortOther
Also called Whole genome sequencing and biomarker analysis
Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
Part 2: Heritable CV Diseases and Family MembersOther
Also called Biomarker analysis
Biomarker analysis will be undertaken on samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Part 1: DCM Cohort | |
| 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. Receives: Other: Part 2: Heritable CV Diseases and Family Members |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of major adverse cardiovascular events over 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start9 Jan 2020
- Primary completion22 Jul 2027 (estimated)
- Study completion16 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- James Ware, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843255
- Sponsor's protocol ID
- 18IC4391
- Acronym
- Go-DCM
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionaries will be shared with collaborating sites
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy: a Prospective Multi-centre Observational Study
- ClinicalTrials.gov ID
- NCT03843255
- Acronym / sponsor ID
- Go-DCM / 18IC4391
- Conditions
- Dilated Cardiomyopathy, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 16 Jun 2029 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dilated Cardiomyopathy patients | – | Other: Part 1: DCM CohortApproximately 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. |
| Part 2: Heritable Cardiovascular Disease | – | Other: Part 2: Heritable CV Diseases and Family MembersPatients 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. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * 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)
Key inclusion criteria (10 listed)
- 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
- Males or females of any age
Key exclusion criteria (17 listed)
- 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:-
- History of primary valvular heart disease or congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1: DCM CohortAlso: Whole genome sequencing and biomarker analysisPatients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis | Other | Part 1: Dilated Cardiomyopathy patients |
| Part 2: Heritable CV Diseases and Family MembersAlso: Biomarker analysisBiomarker analysis will be undertaken on samples | Other | Part 2: Heritable Cardiovascular Disease |
Primary outcome
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:- 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Data dictionaries will be shared with collaborating sites
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ware principal investigator
Imperial College London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Cardiovascular Diseases, run by Imperial College London at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of major adverse cardiovascular events over 5 years (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.