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Trial record 35 of 157 for:    Idiopathic Dilated Cardiomyopathy

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
Sponsor:
Collaborators:
British Heart Foundation
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

Brief 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. 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

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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Other
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


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Chopping 0330 128 2294 s.chopping@imperial.ac.uk
Contact: Chief Investigator 0330 128 2294 go-dcm@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
British Heart Foundation
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: James Ware Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03843255     History of Changes
Other Study ID Numbers: 18IC4391
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries will be shared with collaborating sites
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: During planning (January 2018) and throughout the study recruitment and follow-up period (Dec 2022)
Access Criteria: Provided through secure data transfer mechanisms approved by Imperial College London and secure email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Cardiovascular Diseases
Heart Diseases
Cardiomegaly