China PEACE 5p-HF Study

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

The investigators will consecutively recruit 5000 patients hospitalized for heart failure (HF) from 50 hospitals across China and follow them up for one year, describe treatment patterns during hospitalization and the follow-ups, examine patients recovery trajectory after HF, and identify targets for care quality improvement.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Other: Observational study

Detailed Description

This study will consecutively enroll patients with HF as the primary reason for hospitalization in 50 hospitals scattered all over China. Participants will be interviewed at baseline (i.e., during the index hospitalization for HF), and at 1, 6, and 12 months following hospital discharge. During the follow-up period, participants will be instructed to return to the hospital for interviews by site investigators. Telephone follow-ups will be conducted only when in-person interviews are not feasible.

At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status; during the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period.

The investigators will collect blood and urine samples during index hospitalization and the follow-ups.

This study will examine a series of factors that may affect patients' recovery after HF. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes in the future.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Jing Li, MD, PhD; Phone Number: +86 (10) 6086 6077; Email: jing.li@fwoxford.org
• Study Contact Backup: Name: Yuan Yu, MD; Phone Number: +86 17801013954; Email: yuan.yu@fwoxford.org

Study Locations

• China
  • Xinxiang, China
    • Recruiting
    • Xinxiang Central Hospital
    • Contact: Shuhong Su
    • Principal Investigator: Shuhong Su

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with primary reason for admission of heart failure, aged 18 years or above

Description

• Inclusion Criteria:

  1. Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF
  2. Aged 18 years or above

• Exclusion Criteria:

  1. Patients who have enrolled in this study
  2. Patients who usually do not live in the city/county where the index hospital locates
  3. Patients who are unable to complete interviews due to severe conditions, mental illness, or communication difficulties.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Major adverse cardiac events is defined as the composite of cardiovascular death, resuscitated sudden death, HF-related rehospitalization, myocardial infarction, stroke, and incident atrial fibrillation.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (EQ-5D)		1 year
Depression (PHQ-8)		1 year
Stress (PSS-4)		1 year
Myocardial infarction		1 year
Death	Cardiovascular death and non-cardiovascular death	1 year
Rehospitalization	HF-related and non HF-related	1 year
Resuscitated sudden death		1 year
Stroke		1 year
Incident atrial fibrillation		1 year
Incident renal insufficiency		1 year
Quality of life for HF (KCCQ-12)		1 year
Anxiety (GAD-2)		1 year
Function of cognition (Mini-cog)		1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital	For index hospitalization and accumulative during follow-up	1 year
Length of stay in ICU/CCU for index hospitalization		Duration of hospitalization, average of 10 days
Recurrent hospitalizations during study period		1 year
Invasive procedures		1 year
Prescription of proven therapies during hospitalization among ideal patients	Prescription of proven therapies (for HF medications, including dosage) during hospitalization among ideal patients (with indication and without contraindication)	Duration of hospitalization, average of 10 days
Use of proven therapies during follow-up among ideal patients	Use of proven therapies (for HF medications, including dosage) during follow-up among ideal patients (with indication and without contraindication)	1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Jing Li, MD, PhD, China National Center for Cardiovascular Disease; Principal Investigator: Harlan M Krumholz, MD, SM, Yale University

Publications and helpful links

General Publications

• Xing F, Zheng X, Zhang L, Hu S, Bai X, Hu D, Li B, Li J. Discharge heart rate and 1-year clinical outcomes in heart failure patients with atrial fibrillation. Chin Med J (Engl). 2021 Oct 18;135(1):52-62. doi: 10.1097/CM9.0000000000001768.
• Tian J, Zhao J, Zhang Q, Ren J, Han L, Li J, Zhang Y, Han Q. Assessment of chronic disease self-management in patients with chronic heart failure based on the MCID of patient-reported outcomes by the multilevel model. BMC Cardiovasc Disord. 2021 Jan 30;21(1):58. doi: 10.1186/s12872-021-01872-3.
• Huang X, Yu Y, Li X, Masoudi FA, Spertus JA, Yan X, Krumholz HM, Jiang L, Li J. The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design. BMJ Open. 2019 Feb 19;9(2):e025144. doi: 10.1136/bmjopen-2018-025144.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 20, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: heart failure; cohort; prospective
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2015BAI12B02-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided