China National Heart Failure Registry

Congestive Heart Failure Clinical Trial

— CN-HF  

Official title:

The National Registry Study of Hospitalized Heart Failure Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02079428
• Other study ID #: 2011BAI11B10
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2014
• Last updated: March 4, 2014
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2014
• Source: Shanghai Institute of Cardiovascular Diseases
• Contact: Jingmin Zhou, Professor
• Phone: 86 13601954136
• Email: zhou.jingmin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients discharged from the department of cardiology;

• Discharge or death diagnosis involves diseases with I50 as the beginning of the International Classification of Diseases (ICD)-10 code, including congestive heart failure, congestive heart disease, cardiac failure, right side heart failure, right side ventricular failure, acute left side heart failure, chronic left side cardiac dysfunction, cardiac asthma, left side heart failure, left side heart failure with acute pulmonary edema, low cardiac output syndrome, cardiac dysfunction, acute heart failure, chronic heart failure, grade ? cardiac function class, grade ? cardiac function class, grade ?-? cardiac function class, grade ? cardiac function class, heart failure, cardiac-renal failure, circulatory failure, and grade ?cardiac function class (I51.903), pregnancy with heart failure (O99.408), pregnancy with cardiac dysfunction (O99.429), postpartum cardiac dysfunction (O99.434), post-operative heart failure with pulmonary edema (I97.104), and heart failure after cardiac surgery (I97.106);

• Agree to sign an informed consent form.

Exclusion Criteria:

• Refuse to sign an informed consent form;

• Already involved in this study during previous hospitalization.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Failure
• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• No interventions

Locations

Country	Name	City	State
China	Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in New York Heart Association (NYHA) cardiac function classes		36 months after index discharge	No
Primary	Number of death		36 months after index discharge	No
Secondary	Number of patients rehospitalized for worsened heart failure		36 months after index discharge	No