DCM - Dilated CardiomyopathyNCT04837612
Observational Study for Patients With Dilated Cardiomyopathy
An observational study of DCM - Dilated Cardiomyopathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Observational study on patients with dilated cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis of patients with dilated cardiomyopathy, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of dilated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- DCM - Dilated Cardiomyopathy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography.
Who may be able to join
None listed.
Who cannot join
- Cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease, Patients who had underwent heart transplatation. Individuals not suitable for the present study due to maligant tumor or severe trauma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong cardiovascular institute
Guangzhou, Guangdong, 510080
Cheng Huang, PhD, 020-83827812 ext. 020-83827812, linfeng7822@sina.com
Qi Zhong, PhD, 020-83827812 ext. 020-83827812, zhongqi219@126.com
About this study
Observational study on patients with dilated cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis of patients with dilated cardiomyopathy, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of dilated cardiomyopathy. Therefore, endpoints indluding all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.
Read the detailed description
In this observational study on patients with dilated cardiomyopathy, 500 eligible patients, who were diagnosed as dilated cardiomyopathy by echocardiography, will be recruited with a median follow up of 5 years.Patients will be excluded who develop cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease; who had underwent heart transplatation; who are not suitable for the present study due to maligant tumor or severe trauma.
Eligible individuals, identified based on echocardiography and medical records, were invited to a community clinic by phone. For eligible individuals, study data were comprised of a self-administered questionnaire, anthropometric features, laboratory examinations, echocardiographic and/or cardiac magetic resnonance data. Anthropometric data were measured by experienced research staff in the morning under standardized conditions. Echocardiographic measuring were performed by three skilled sonographers independently, based on routine protocols on an HP5500 (Phillips Medical System, Boston, Massachusetts, USA) per current guidelines. Venous blood samples were collected in the morning following overnight fasting. Laboratory procedures were performed under standardized conditions.
Endpoints including all-cause mortality, cardiovascular death, sudden death (ICD-Code I46.1, R96), ventricular tachycardia(ICD-code I47.2)/fibrillation/flutter(ICD-code I49.0), hospitalization for heart failure(ICD-Code I50), heart transplatation ((ICD-Code Z94.1), non-fatal stroke(ICD-Code I60, I61, I63, I64), non-fatal myocardial infarction (ICD-Code I21), sudden death (ICD-Code I46.1, R96), successful cardiopulmonary resuscitation (ICD-Code I46.0) will be evaulated.
Across the whole observational study, 50 endpoints are anticipated to occur annually, and therefore the sample size was estimated to be approximately 500 subjects.
Data collection and management will be conducted via electronic data collection (EDC). Source data will be checked regularly to assess the accuracy and completeness. For statistical analysis, continuous variables are presented as mean±standard deviation (SD), and compared by the Student t-test. Categorical variables are presented as frequency and assessed by the χ2 test. SAS 9.4 for Windows (release 6.11, USA) is to be utilized for statistical analysis.
- Conditions
- DCM - Dilated Cardiomyopathy
- Being tested
- No intervention nor exposure
- Keywords
- all-cause mortality, cardiovascular death, hospitalization for heart failure, heart transplatation
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention nor exposureOther
As an observational study, no intervention nor exposure is interested.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with dilated cardiomyopathy | Subjects diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography. Receives: Other: No intervention nor exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
All-cause mortality refers to death from any causes.
Measured: 5 YEARS.
Secondary outcomes (8)
Cardiovascular death
Cardiovascular death include death caused by stroke, MI, HF, sudden death or any other death attributed to cardiovascular diseases.
Measured: 5 YEARS.
Ventricular tachycardia and fibrillation and flutter
Ventricular tachycardia is an abnormally fast heart beat (with three or more consecutive heart beats at least 100 beats per minute) that originates from one of the ventricles in the heart (ICD-code I47.2), respectively.Ventricular fibrillation (VF) is a very rapid (150-500 bpm) irregularly irregular disorganized ventricular rhythm of varying configuration; with time, the amplitude of the fibrillation wave becomes progressively smaller, particularly immediately before death. Ventricular flutter (VFL) is a very rapid (180-250 bpm) and regular ectopic ventricular rhythm with undulations of equal amplitude and usually rapidly degenerates to VF(ICD-code I49.0).
Measured: 5 YEARS.
nonfatal stroke
Stroke (ICD-Code I60, I61, I63, I64) is a focal neurological deficit with symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular. Stroke as an endpoint in this study includes definite ischemic stroke, primary intracerebral hemorrhage and subarachnoid hemorrhage with evidence from CT or MRI scan within 14 days of onset or autopsy confirmation, and stroke of unknown type etiology when CT, MRI, or autopsy are not done and information is inadequate to diagnose the etiology definitely.
Measured: 5 YEARS.
nonfatal myocardial infarction
Acute myocardial infarction (MI) (ICD-Code I21) is defined when any one of the following criteria occurs. (1) Detection of a rise and/or fall of cardiac biomarker values, with at least one value above the 99th percentile upper reference limit and with at least one of the following manifestations: symptoms of ischaemia that should have lasted for at least 30 minutes and should not have been responsive to sublingual administration of nitrates; new or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB); development of pathological Q waves in the ECG; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. (2) Identification of an intracoronary thrombus by angiography or autopsy. (3) Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.
Measured: 5 YEARS.
sudden death
Sudden death (ICD-Code I46.1, R96) encompasses any death of unknown origin occurring instantly or within an estimated 24 hours after the onset of acute symptoms as well as unattended death for which no likely cause can be established by autopsy or recent medical history.
Measured: 5 YEARS.
Cardiac arrest with successful resuscitation
ICD-Code I46.0
Measured: 5 YEARS.
Hospitalization for heart failure
Congestive heart failure (HF) (ICD-Code I50) requires the presence of three conditions, namely symptoms, such as dyspnea, clinical signs, such as ankle edema or crepitations, and the necessity to initiate treatment with open-label diuretics, vasodilators or antihypertensive drugs. HF cases may also be adjudicated as chronic stable HF but this is not considered an outcome of the present study.
Measured: 5 YEARS
Heart transplatation
Heart replaced by heterogenous or homogenoustransplant due to end-stage heart failure. (ICD-Code Z94.1).
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 posted8 Apr 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCM - 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Huang, Guangdong Provincial People's Hospital
- Investigators
- Cheng Huang, PhD, Principal investigator, Guangdong Cardiovascular institute, Dongchuan Road,96#, Guangzhou City, Guangdong Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837612
- Sponsor's protocol ID
- GDREC2019546HR1
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A part of participants do not want their privacy to be shared by other reserchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04837612
- Acronym / sponsor ID
- GDREC2019546HR1
- Conditions
- DCM - Dilated Cardiomyopathy
- Keywords
- all-cause mortality, cardiovascular death, hospitalization for heart failure, heart transplatation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Apr 2021 (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.
Observational study on patients with dilated cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis of patients with dilated cardiomyopathy, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of dilated cardiomyopathy. Therefore, endpoints indluding all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.
Detailed description
In this observational study on patients with dilated cardiomyopathy, 500 eligible patients, who were diagnosed as dilated cardiomyopathy by echocardiography, will be recruited with a median follow up of 5 years.Patients will be excluded who develop cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease; who had underwent heart transplatation; who are not suitable for the present study due to maligant tumor or severe trauma.
Eligible individuals, identified based on echocardiography and medical records, were invited to a community clinic by phone. For eligible individuals, study data were comprised of a self-administered questionnaire, anthropometric features, laboratory examinations, echocardiographic and/or cardiac magetic resnonance data. Anthropometric data were measured by experienced research staff in the morning under standardized conditions. Echocardiographic measuring were performed by three skilled sonographers independently, based on routine protocols on an HP5500 (Phillips Medical System, Boston, Massachusetts, USA) per current guidelines. Venous blood samples were collected in the morning following overnight fasting. Laboratory procedures were performed under standardized conditions.
Endpoints including all-cause mortality, cardiovascular death, sudden death (ICD-Code I46.1, R96), ventricular tachycardia(ICD-code I47.2)/fibrillation/flutter(ICD-code I49.0), hospitalization for heart failure(ICD-Code I50), heart transplatation ((ICD-Code Z94.1), non-fatal stroke(ICD-Code I60, I61, I63, I64), non-fatal myocardial infarction (ICD-Code I21), sudden death (ICD-Code I46.1, R96), successful cardiopulmonary resuscitation (ICD-Code I46.0) will be evaulated.
Across the whole observational study, 50 endpoints are anticipated to occur annually, and therefore the sample size was estimated to be approximately 500 subjects.
Data collection and management will be conducted via electronic data collection (EDC). Source data will be checked regularly to assess the accuracy and completeness. For statistical analysis, continuous variables are presented as mean±standard deviation (SD), and compared by the Student t-test. Categorical variables are presented as frequency and assessed by the χ2 test. SAS 9.4 for Windows (release 6.11, USA) is to be utilized for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with dilated cardiomyopathy | – | Other: No intervention nor exposureSubjects diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease, Patients who had underwent heart transplatation. Individuals not suitable for the present study due to maligant tumor or severe trauma.
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 |
|---|---|---|
| No intervention nor exposureAs an observational study, no intervention nor exposure is interested. | Other | Subjects with dilated cardiomyopathy |
Primary outcome
All-cause death
Time frame: 5 YEARS.
All-cause mortality refers to death from any causes.
8 secondary outcomes
Cardiovascular death
Time frame: 5 YEARS.
Ventricular tachycardia and fibrillation and flutter
Time frame: 5 YEARS.
nonfatal stroke
Time frame: 5 YEARS.
nonfatal myocardial infarction
Time frame: 5 YEARS.
sudden death
Time frame: 5 YEARS.
Cardiac arrest with successful resuscitation
Time frame: 5 YEARS.
Hospitalization for heart failure
Time frame: 5 YEARS
Heart transplatation
Time frame: 5 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No. A part of participants do not want their privacy to be shared by other reserchers.
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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.
Cheng Huang, PhD principal investigator
Guangdong Cardiovascular institute, Dongchuan Road,96#, Guangzhou City, Guangdong Province
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 DCM - Dilated Cardiomyopathy, run by Guangdong Provincial People's 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 0 inclusion and 1 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 8 Apr 2021. 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 Cheng Huang, PhD (020-83827812 ext. 020-83827812, linfeng7822@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 5 YEARS.). 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 8 Apr 2021.