Congenital Heart Disease (CHD)NCT06885307
Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China
An observational study of Congenital Heart Disease (CHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 6 sites in China.
Trial summary
This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- How many people
- 35,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jun 2019to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination
Who may be able to join
- Age 0-18 years, regardless of gender;
- Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan
Bo Han, MD, PhD, 13605313927, hanbo35@163.com
- Recruiting
Kunming Children's Hospital
Kunming, Yunnan, 650034
Jieqing Min, 13888867101
- Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Lijun Fu, MD, 18930830840, fulijun@scmc.com.cn
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Maoping Chu, MD, 13506670567, chmping@126.com
- Recruiting
Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430016
Yong Zhang, MM, 13886842352
- Recruiting
Qinghai Women & Children'S Hospital
Xining, Qinghai, 810007
Xiulian Jiang, 15003664082, qhjxl6707@sina.com
About this study
This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the collection and sharing of data on children with congenital heart disease in China, and create a real-world public database of children with congenital heart disease in China that benchmarks the international level, so as to provide a solid data foundation for high-quality research on children with congenital heart disease in China.
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Congenital Heart Disease (CHD), Database
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of condition
The discharge records were extracted and written by the attending doctor, and the values were divided into cured, improved, unhealed, and died
Measured: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jun 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Retrospective
- Enrolment
- 35,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kun Sun, MD, Principal investigator, Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885307
- Sponsor's protocol ID
- XHEC-C-2024-159-1
- Status last verified
- Feb 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China
- ClinicalTrials.gov ID
- NCT06885307
- Acronym / sponsor ID
- XHEC-C-2024-159-1
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Congenital Heart Disease (CHD), Database
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (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 project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the collection and sharing of data on children with congenital heart disease in China, and create a real-world public database of children with congenital heart disease in China that benchmarks the international level, so as to provide a solid data foundation for high-quality research on children with congenital heart disease in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination
Key inclusion criteria (2 listed)
- Age 0-18 years, regardless of gender;
- Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;
Key exclusion criteria (1 listed)
- None
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
Change of condition
Time frame: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery
The discharge records were extracted and written by the attending doctor, and the values were divided into cured, improved, unhealed, and died
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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.
Kun Sun, MD principal investigator
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 6 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 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Sun, MD (8621-25076045, drsunkun@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of condition (time frame: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery). 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 20 Mar 2025.