Clinical trial NCT02878811: China PEACE 5p-HF Study
Official title: China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Heart Failure (HF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure
prospective
cohort
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2016-08-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with primary reason for admission of heart failure, aged 18 years or above

Brief summary: 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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Rehospitalization
timeFrame: 1 year
measure: Resuscitated sudden death
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Incident atrial fibrillation
timeFrame: 1 year
measure: Incident renal insufficiency
timeFrame: 1 year
measure: Quality of life (EQ-5D)
timeFrame: 1 year
measure: Quality of life for HF (KCCQ-12)
timeFrame: 1 year
measure: Depression (PHQ-8)
timeFrame: 1 year
measure: Stress (PSS-4)
timeFrame: 1 year
measure: Anxiety (GAD-2)
timeFrame: 1 year
measure: Function of cognition (Mini-cog)
timeFrame: 1 year
Other outcomes:
measure: Length of stay in hospital
timeFrame: 1 year
measure: Length of stay in ICU/CCU for index hospitalization
timeFrame: Duration of hospitalization, average of 10 days
measure: Recurrent hospitalizations during study period
timeFrame: 1 year
measure: Invasive procedures
timeFrame: 1 year
measure: Prescription of proven therapies during hospitalization among ideal patients
timeFrame: Duration of hospitalization, average of 10 days
measure: Use of proven therapies during follow-up among ideal patients
timeFrame: 1 year
Locations:
city: Xinxiang
country: China
facility: Xinxiang Central 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: 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). 2022 Jan 5;135(1):52-62. doi: 10.1097/CM9.0000000000001768.
citation: 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.
citation: 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.