Dilated Cardiomyopathy (DCM)NCT00523653
The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study
An observational study of Dilated Cardiomyopathy (DCM), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy (DCM)
- What is being tested?
- blood test
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Dilated cardiomyopathy followed at the Heart Function Clinic and their families
Who may be able to join
- Followed at MUHC Heart Function Centre
- Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm.
- Patient's written consent
Who cannot join
- Patients with a known underlying condition that results in a weakened and enlarged heart
- Patients unable to read and understand the consent form
- Patients who do not wish to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Nadia Giannetti, MD, nadia.giannetti@muhc.mcgill.ca
About this study
Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.
- Conditions
- Dilated Cardiomyopathy (DCM)
- Being tested
- blood test
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
looking at DNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJan 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Cardiomyopathy (DCM)Studies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Nadia S Giannetti, MD, Principal investigator, McGill University Hospital CentreJamie Engert, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523653
- Sponsor's protocol ID
- BMB 07-004
- Status last verified
- Mar 2008
- First submitted
- 29 Aug 2007
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study
- ClinicalTrials.gov ID
- NCT00523653
- Acronym / sponsor ID
- BMB 07-004
- Conditions
- Dilated Cardiomyopathy (DCM)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Dec 2008 (estimated)
- First posted
- 31 Aug 2007 (estimated)
- 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.
Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Dilated cardiomyopathy followed at the Heart Function Clinic and their families
Key inclusion criteria (3 listed)
- Followed at MUHC Heart Function Centre
- Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm.
- Patient's written consent
Key exclusion criteria (3 listed)
- Patients with a known underlying condition that results in a weakened and enlarged heart
- Patients unable to read and understand the consent form
- Patients who do not wish to participate
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 |
|---|---|---|
| blood testlooking at DNA | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
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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.
Nadia S Giannetti, MD principal investigator
McGill University Hospital Centre
Jamie Engert, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site 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 (DCM), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia S Giannetti, MD ((514)934 1934 ext. 32850, nadia.giannetti@much.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Mar 2008.