Dilated CardiomyopathyAOCCNCT03076580
An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China
An observational study of Dilated Cardiomyopathy and Hypertrophic Cardiomyopathy, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 3 sites in China.
Trial summary
This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy
- How many people
- 2,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2015to 31 Dec 2021
- 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: A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence. Patients have smiliar symptoms and are suspected as cardiomyopathy and further excluded by imaging examnation. age- and gender- mathced healthy controls are also recuitted in the hospital.
Who may be able to join
- Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.
Who cannot join
- Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
- History of rheumatic fever
- Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
- HIV infection or born to an HIV positive mother
- Kawasaki disease
- Immunologic disease
Show all 9Show fewer
- Uremia, active or chronic
- Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia
- 10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
Trial locations and contacts
3 sites in 1 country.
Jie Du, PhD contact
Yulin Li, PhD contact
China3 sites, 3 recruiting
- Recruiting
Beijing Institute of heart, lung and blood vessel diseases
Beijing, Beijing Municipality
Jie Du, jiedubj@126.com
Yulin Li, lyllyl_1111@163.com
- Recruiting
Beijing Institute of heart, lung and blood vessel diseases
Beijing, Beijing Municipality
Jie Du, jiedubj@126.com
Yulin Li, lyllyl_1111@163.com
- Enrolling by invitation
Shijie You
Beijing
About this study
Official title: An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.
Read the detailed description
Identification of novel biomarkers is needed to improve the diagnosis and prognosis of cardiomyopathy. Also,the marked variation of genes which is still unclear, may influence clinical outcomes is determined in part by genetic heterogeneity of the systemic response to pathological process.
Specific aim:
- Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
- Genomics will be to determine the association of clinical outcome
- Conditions
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction, Restrictive Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Arrhythmogenic Right Ventricular Dysplasia, Cardiomyopathy, Restrictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiomyopathy | Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| disease control | Patients have similar symptoms with cardiomyopathy patients, and are further excluded by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| healthy control | Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
The primary objective of this study is to determine whether variation in genetic background or molecules influences clinical outcomes in cardiomyopathy. Differentially expressed molecules are reported in multi-omics.
Measured: Five year
Secondary outcomes (23)
Age for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
gender for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Past medical history for each participant including disease history, surgical history, and family
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Life style for each participant including smoking history and drinking, specify how many years
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood lipids(LDL,HDL,VLDL)
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
creatine
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
urea
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood glucose
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
D-dimer
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
hsCRP
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
All-cause death
The data is collected during follow-up visit at 1/3/5 years after discharge
Measured: One year/Three year/Five year
Re-hospitalization
Patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction or worsen symptoms. The data is collected during follow-up visit at 1/3/5 years after discharge
Measured: One year/Three year/Five year
Heart transplantation
Patients are underwent heart transplantation due to "pump failure of heart".The data is collected during follow-up visit at 1/3 years after discharge
Measured: One year/Three year/Five year
Malignant arrythmia
Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
Measured: One year/Three year/Five year
Worsening heart failure
Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction <45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36/60 months after enrollment.
Measured: One year/Three year/Five year
RNA/micro RNA/long-noncoding RNA-sequencing data
Measured: The data is collected from lab in an average of 6 month after the sample recruiting
Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample
Measured: The data is collected from lab in an average of 6 month after the sample recruiting
Exon sequencing data
Measured: The data is collected from lab in an average of 6 month after the sample recruiting
Result of echocardiography-Ejection Fraction
The whole results of echocardiography report will be recorded. The indicate can reflect cardiac contraction function and be used for discriminating heart failure or non-heart failure as a main factor.
Measured: Three year
Result of echocardiography-Left Ventricular End Diastolic Diameter
The whole results of echocardiography report will be recorded. The indicate can reflect the size of heart and be used for determination of heart enlargement.
Measured: Three year
Result of echocardiography-E/A Ratio
The whole results of echocardiography report will be recorded. The indicate can reflect diastolic function.
Measured: Three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Jul 2015
- Primary completion1 Jul 2018 (estimated)
- Study completion31 Dec 2021 (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 Dilated CardiomyopathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Du, PhD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076580
- Sponsor's protocol ID
- BeijingIHLBVD2016031
- Acronym
- AOCC
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma K, Yang J, Guo H, Li P, Li X, Dong Z, Zhang J, Zhang C, Yang P, Hua C, Zhu S, Li G, Zhang J, Ding N, Wang J, Ma XL, Lin Z, Dong J, Li Y, Li Y. Proteogenomics of Hypertrophic Cardiomyopathy Reveals Subtype-Specific Therapy. Circ Res. 2026 Jul 31;139(4):e328300. doi: 10.1161/CIRCRESAHA.126.328300. Epub 2026 Jul 1.
PubMed 42381624
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative-omics Study to Identify New Biomarkers of Cardiomyopathy Patients in China
- ClinicalTrials.gov ID
- NCT03076580
- Acronym / sponsor ID
- AOCC / BeijingIHLBVD2016031
- Conditions
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction, Restrictive Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Mar 2017 (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.
This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.
Detailed description
Identification of novel biomarkers is needed to improve the diagnosis and prognosis of cardiomyopathy. Also,the marked variation of genes which is still unclear, may influence clinical outcomes is determined in part by genetic heterogeneity of the systemic response to pathological process.
Specific aim:
- Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
- Genomics will be to determine the association of clinical outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cardiomyopathy | – | –Patients are diagnosed as cardiomyopathy by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
| disease control | – | –Patients have similar symptoms with cardiomyopathy patients, and are further excluded by three cardiologists and recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
| healthy control | – | –Healthy subjects are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence. Patients have smiliar symptoms and are suspected as cardiomyopathy and further excluded by imaging examnation. age- and gender- mathced healthy controls are also recuitted in the hospital.
Key inclusion criteria (2 listed)
- Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.
Key exclusion criteria (9 listed)
- Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
- History of rheumatic fever
- Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
- HIV infection or born to an HIV positive mother
- Kawasaki disease
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
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy.
Time frame: Five year
The primary objective of this study is to determine whether variation in genetic background or molecules influences clinical outcomes in cardiomyopathy. Differentially expressed molecules are reported in multi-omics.
23 secondary outcomes
Age for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
gender for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Past medical history for each participant including disease history, surgical history, and family
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Life style for each participant including smoking history and drinking, specify how many years
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood lipids(LDL,HDL,VLDL)
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
creatine
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
urea
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood glucose
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
D-dimer
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
hsCRP
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
All-cause death
Time frame: One year/Three year/Five year
Re-hospitalization
Time frame: One year/Three year/Five year
Heart transplantation
Time frame: One year/Three year/Five year
Malignant arrythmia
Time frame: One year/Three year/Five year
Worsening heart failure
Time frame: One year/Three year/Five year
RNA/micro RNA/long-noncoding RNA-sequencing data
Time frame: The data is collected from lab in an average of 6 month after the sample recruiting
Proteomics on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer of plasma sample
Time frame: The data is collected from lab in an average of 6 month after the sample recruiting
Exon sequencing data
Time frame: The data is collected from lab in an average of 6 month after the sample recruiting
Result of echocardiography-Ejection Fraction
Time frame: Three year
Result of echocardiography-Left Ventricular End Diastolic Diameter
Time frame: Three year
Result of echocardiography-E/A Ratio
Time frame: Three year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 42381624Ma K, Yang J, Guo H, Li P, Li X, Dong Z, Zhang J, Zhang C, Yang P, Hua C, Zhu S, Li G, Zhang J, Ding N, Wang J, Ma XL, Lin Z, Dong J, Li Y, Li Y. Proteogenomics of Hypertrophic Cardiomyopathy Reveals Subtype-Specific Therapy. Circ Res. 2026 Jul 31;139(4):e328300. doi: 10.1161/CIRCRESAHA.126.328300. Epub 2026 Jul 1.
- 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.
Jie Du, PhD contact
Yulin Li, PhD contact
Jie Du, PhD study chair
Beijing Anzhen Hospital
3 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 Hypertrophic Cardiomyopathy, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 3 sites 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 2 inclusion and 9 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Jie Du, PhD (jiedubj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to determine whether variation in genetic background or differentially expressed molecules influences clinical outcomes in cardiomyopathy. (time frame: Five year). 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 NCT03076580, 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 19 Apr 2018.