China National Heart Failure Registry (CN-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Shanghai Institute of Cardiovascular Diseases
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT02079428
First received: March 2, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cardiac Failure
Congestive Heart Failure
Other: No interventions

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

Resource links provided by NLM:


Further study details as provided by Shanghai Institute of Cardiovascular Diseases:

Primary Outcome Measures:
  • Number of death [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients rehospitalized for worsened heart failure [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in New York Heart Association (NYHA) cardiac function classes [ Time Frame: 36 months after index discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
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)
Groups/Cohorts Assigned Interventions
Systolic heart failure, Diastolic heart failure 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079428

Contacts
Contact: Jingmin Zhou, Professor 86 13601954136 zhou.jingmin@zs-hospital.sh.cn

Locations
China
Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Jun Zhou, MD    86 13817582260    zhou.jun@zs-hospital.sh.cn   
Principal Investigator: Jingmin Zhou, Professor         
Sponsors and Collaborators
Shanghai Institute of Cardiovascular Diseases
Investigators
Principal Investigator: Jingmin Zhou, Professor Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Institute of Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT02079428     History of Changes
Other Study ID Numbers: 2011BAI11B10
Study First Received: March 2, 2014
Last Updated: March 4, 2014
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Institute of Cardiovascular Diseases:
Heart Failure
Registry
China

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014