NCT02079428

China National Heart Failure Registry

The National Registry Study of Hospitalized Heart Failure Patients in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Shanghai Institute of Cardiovascular Diseases · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of CN-HF is to establish the national registration of hospitalized heart failure patients, evaluate and compare the clinical features and prognosis of diastolic and systolic heart failure, and find out the status of treatment and implementation of guidelines on heart failure in China.

Detailed description

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.

Conditions

• Cardiac Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
OTHER	No interventions

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2014-03-05
• Last updated: 2014-03-05

Locations

1 site across 1 country: China