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RecruitingNCT06885307Updated Mar 20, 2025

Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China

An observational study in Congenital Heart Disease (CHD), sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 6 sites in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2019; still recruiting 7 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
35,000
Ages
Up to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Congenital Heart Disease (CHD)

Keywords

  • Congenital Heart Disease (CHD)
  • Database
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 35,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination

Inclusion criteria

  1. Age 0-18 years, regardless of gender;
  2. Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
35,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery

07

Study locations

6 of 6 sites recruiting
  • Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430016, China
    • Yong Zhang, MM · Contact · 13886842352
    Recruiting
  • Qinghai Women & Children'S Hospital
    Xining, Qinghai 810007, China
    Recruiting
  • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200127, China
    Recruiting
  • Kunming Children's Hospital
    Kunming, Yunnan 650034, China
    • Jieqing Min · Contact · 13888867101
    Recruiting
  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325027, China
    Recruiting
  • Shandong Provincial Hospital Affiliated to Shandong First Medical University
    Jinan, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06885307
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Kun Sun (Professor of Department of Pediatric Cardiology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Mar 20, 2025
Start date
Jun 1, 2019
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Mar 20, 2025

Study contacts

Kun Sun, MD
Contact
drsunkun@xinhuamed.com.cn
8621-25076045
Kun Sun, MD
principal investigator · Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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