China PEACE 5r-HF Study

Heart Failure Clinical Trial

Official title:

China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Retrospective Study of Patients With Heart Failure (HF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877914
• Other study ID #: 2015BAI12B02-1
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: December 4, 2017
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: December 2017
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, MD, PhD
• Phone: +86 (10) 6086 6077
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality improvement.

Description:

This study will use a two-stage random sampling design to create a nationally representative sample in China, and randomly sample patients with HF as a primary diagnosis, and were admitted to hospital from January 1st, 2015 to December 31st, 2015. The sample size is estimated to be 10,000.

The investigators will collect photocopies of the sampled medical records and centrally abstract detailed information, which included demographic characteristics, medical history, clinical features, diagnostic tests, in-hospital procedures, lab tests, treatments, and in-hospital outcomes. Data abstraction quality was monitored by random auditing of 5% of the medical records, with overall variable accuracy exceeding 98%.

Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results across regions and hospitals. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes for HF in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF?

• Hospitalized during January 1st, 2015 to December 31st, 2015

• Aged 18 years or above

Exclusion Criteria:

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Observational study
This is a non-interventional study, patients receive their usual treatment as determined by the physician.

Locations

Country	Name	City	State
China	Zhengzhou People's Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		Duration of hospitalization, an average of 10 days