China National Heart Failure Registry (CN-HF)
Recruitment status was: Recruiting
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Years|
|Official Title:||The National Registry Study of Hospitalized Heart Failure Patients in China|
- Number of death [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]
- Number of patients rehospitalized for worsened heart failure [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]
- Change from baseline in New York Heart Association (NYHA) cardiac function classes [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Systolic heart failure, Diastolic heart failure||Other: No interventions|
The CN-HF is a national, multi-centered, prospective and observational registry study, led by Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital (head unit) with 50 to 100 secondary and tertiary hospitals involved. The study planed to consecutively enroll 10 000 heart failure patients fulfilling the inclusion criteria. Each center will register all patients with heart failure involved in the discharge or death diagnosis in consecutive 6 months, and each registered patient will be followed up for at least 3 years. The study consists 3 phases: the screening phase, the baseline registry phase, and the follow-up registry phase.
The data collecting and reporting will employ the combination of paper-based case report form (CRF) and web-based electronic CRF. The handwriting paper CRF are provided by the head unit as raw data. Investigators in each center should input the raw data into the web-based CRF using the login name and password provided by the head unit.
The data management center specified by the head unit is responsible for the establishment and maintenance of CRF and the central database, the regular check of data submitted and the updating of the database. During the data collection, the data management center will also regularly check and report errors in the CRF and feedback to each centers and supervise to correct errors.
At the end of the study, the database will be locked after all data being checked and updated. Each participating center will preserve their own copy of paper-based CRF and electronic CRF, the head unit will preserve all paper-based CRFs and electronic CRFs.
Statistical analysis will be performed by independent statisticians in the head unit (Shanghai Institute of Cardiovascular Diseases) using the SAS software. The Student t test or chi-square test will be used for comparison between two groups. The Cox proportional hazard model will be used to investigate the risk factors for adverse cardiovascular events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02079428
|Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University|
|Shanghai, China, 200032|
|Principal Investigator:||Jingmin Zhou, Professor||Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University|