Clinical trial NCT02877914: China PEACE 5r-HF Study
Official title: China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Retrospective Study of Patients With Heart Failure (HF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure, retrospective
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2016-08-24
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with primary reason for admission of heart failure, aged 18 years or above

Brief 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.

Detailed 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.

Eligibility criteria: 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:

* None

Primary outcomes:
measure: Death
timeFrame: Duration of hospitalization, an average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
Study officials:
affiliation: China National Center for Cardiovascular Disease
name: Jing Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu Y, Guan W, Masoudi FA, Wang B, He G, Spertus JA, Lu Y, Krumholz HM, Li J. Hospital Variation of Spironolactone Use in Patients Hospitalized for Heart Failure in China-The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2022 Oct 4;11(19):e026300. doi: 10.1161/JAHA.122.026300. Epub 2022 Sep 29.
citation: Yu Y, Gupta A, Wu C, Masoudi FA, Du X, Zhang J, Krumholz HM, Li J; China PEACE Collaborative Group. Characteristics, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Sep 3;8(17):e012884. doi: 10.1161/JAHA.119.012884. Epub 2019 Aug 21.
citation: Yu Y, Spatz ES, Tan Q, Liu S, Lu Y, Masoudi FA, Schulz WL, Krumholz HM, Li J; China PEACE Collaborative Group. Traditional Chinese Medicine Use in the Treatment of Acute Heart Failure in Western Medicine Hospitals in China: Analysis From the China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Aug 6;8(15):e012776. doi: 10.1161/JAHA.119.012776. Epub 2019 Jul 31.
citation: Yu Y, Zhang H, Li X, Lu Y, Masoudi FA, Krumholz HM, Li J. The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design. BMJ Open. 2018 May 10;8(5):e020918. doi: 10.1136/bmjopen-2017-020918.