CardiomyopathyNCT03754101
Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants
An observational study of Cardiomyopathy, run by Tongji Hospital at 1 site in China.
Trial summary
Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2003to 31 Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: hospitalized patients with cardiomyopathy will be enrolled in this study
Who may be able to join
- Patients diagnosed as cardiomyopathy according to the definition of American Heart Association
Who cannot join
- Uncontrolled hypertension significant valvular disease
- Mild ischemic heart disease
- Significant systemic infection
- Thyroid-induced cardiomyopathy
- Excessive alcohol consumption
- Precious cancer treatment including irradiation
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Chenze Li, MD candidate, 86-27-83663280, lichenze@126.com
About this study
Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.
- Conditions
- Cardiomyopathy
- Medical subject headings
- Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death confirmed by death comfirmation or interview with the relatives
Death from cardiovascular causes and any unknown death unless there was another certain cause
Measured: up to 24 months
Heart transplantation confirmed by medical record
Heart transplantation within 24 months
Measured: up to 24 months
Secondary outcomes (2)
All cause death confirmed by death comfirmation or interview with the relatives
Any death at hospital or after discharge
Measured: up to 24 months
Heart failure recurring confirmed by medical record
Recurrence of heart failure at hospital or after discharge
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start3 Mar 2003
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Doctor, Study chair, Tongji Hospital,Wuhan, Hubei, China, 430030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754101
- Sponsor's protocol ID
- TJ-DM-GENE
- Status last verified
- Feb 2023
- First submitted
- 1 Nov 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li S, Sun Y, Hu S, Hu D, Li C, Xiao L, Chen Y, Li H, Cui G, Wang DW. Genetic risk scores to predict the prognosis of chronic heart failure patients in Chinese Han. J Cell Mol Med. 2020 Jan;24(1):285-293. doi: 10.1111/jcmm.14722. Epub 2019 Oct 31.
PubMed 31670483
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants
- ClinicalTrials.gov ID
- NCT03754101
- Acronym / sponsor ID
- TJ-DM-GENE
- Conditions
- Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 3 Mar 2003 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 27 Nov 2018 (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.
Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hospitalized patients with cardiomyopathy will be enrolled in this study
Key inclusion criteria (1 listed)
- Patients diagnosed as cardiomyopathy according to the definition of American Heart Association
Key exclusion criteria (7 listed)
- Uncontrolled hypertension significant valvular disease
- Mild ischemic heart disease
- Significant systemic infection
- Thyroid-induced cardiomyopathy
- Excessive alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death confirmed by death comfirmation or interview with the relatives
Time frame: up to 24 months
Death from cardiovascular causes and any unknown death unless there was another certain cause
Heart transplantation confirmed by medical record
Time frame: up to 24 months
Heart transplantation within 24 months
2 secondary outcomes
All cause death confirmed by death comfirmation or interview with the relatives
Time frame: up to 24 months
Heart failure recurring confirmed by medical record
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 31670483Li S, Sun Y, Hu S, Hu D, Li C, Xiao L, Chen Y, Li H, Cui G, Wang DW. Genetic risk scores to predict the prognosis of chronic heart failure patients in Chinese Han. J Cell Mol Med. 2020 Jan;24(1):285-293. doi: 10.1111/jcmm.14722. Epub 2019 Oct 31.
- Individual participant dataSharing planned: Undecided
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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.
Dao Wen Wang, Doctor study chair
Tongji Hospital,Wuhan, Hubei, China, 430030
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 Cardiomyopathy, run by Tongji Hospital at 1 site in China.
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 1 inclusion and 7 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 17 Feb 2023. 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 China. 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 Chenze Li, MD candidate (86-27-83663280, lichenze@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death confirmed by death comfirmation or interview with the relatives (time frame: up to 24 months). 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?
On the ClinicalTrials.gov record for NCT03754101, which also lists 1 linked publication.
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 17 Feb 2023; AzTrials last refreshed its copy on 3 Nov 2026.