China National Heart Failure Registry (CN-HF)

The National Registry Study of Hospitalized Heart Failure Patients in China

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.

Study Overview

• Status: Unknown
• Conditions: Congestive Heart Failure; Cardiac Failure
• Intervention / Treatment: Other: No interventions

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jingmin Zhou, Professor; Phone Number: 86 13601954136; Email: zhou.jingmin@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
    • Contact: Jun Zhou, MD; Phone Number: 86 13817582260; Email: zhou.jun@zs-hospital.sh.cn
    • Principal Investigator: Jingmin Zhou, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Ⅱ cardiac function class, grade Ⅲ cardiac function class, grade Ⅱ-Ⅲ cardiac function class, grade Ⅳ cardiac function class, heart failure, cardiac-renal failure, circulatory failure, and grade Ⅰcardiac 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systolic heart failure, Diastolic heart failure	Other: No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of death	36 months after index discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients rehospitalized for worsened heart failure	36 months after index discharge

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in New York Heart Association (NYHA) cardiac function classes	36 months after index discharge

Collaborators and Investigators

• Sponsor: Shanghai Institute of Cardiovascular Diseases
• Investigators: Principal Investigator: Jingmin Zhou, Professor, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University

Publications and helpful links

General Publications

• Zhou J, Cao J, Jin X, Zhou J, Chen Z, Xu D, Yang X, Dong W, Li L, Fan Y, Chen L, Zhong Q, Fu M, Hu K, Ge J; CN-HF investigators. Digoxin is associated with worse outcomes in patients with heart failure with reduced ejection fraction. ESC Heart Fail. 2020 Feb;7(1):138-146. doi: 10.1002/ehf2.12539. Epub 2020 Jan 29.
• Jin X, Cao J, Zhou J, Wang Y, Han X, Song Y, Fan Y, Chen Z, Xu D, Yang X, Dong W, Li L, Chen L, Zhong Q, Fu M, Hu K, Zhou J, Ge J; CN-HF investigators. Outcomes of patients with anemia and renal dysfunction in hospitalized heart failure with preserved ejection fraction (from the CN-HF registry). Int J Cardiol Heart Vasc. 2019 Aug 31;25:100415. doi: 10.1016/j.ijcha.2019.100415. eCollection 2019 Dec.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 2, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Heart Failure; China; Registry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2011BAI11B10