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China PEACE 5p-HF Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02878811
Enrollment
5000
Registered
2016-08-25
Start date
2016-08-31
Completion date
2019-06-30
Last updated
2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, prospective, cohort

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.

Interventions

OTHERObservational study

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

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac events1 yearMajor adverse cardiac events is defined as the composite of cardiovascular death, resuscitated sudden death, HF-related rehospitalization, myocardial infarction, stroke, and incident atrial fibrillation.

Secondary

MeasureTime frameDescription
Stroke1 year
Quality of life (EQ-5D)1 year
Quality of life for HF (KCCQ-12)1 year
Depression (PHQ-8)1 year
Stress (PSS-4)1 year
Anxiety (GAD-2)1 year
Function of cognition (Mini-cog)1 year
Death1 yearCardiovascular death and non-cardiovascular death
Rehospitalization1 yearHF-related and non HF-related
Resuscitated sudden death1 year
Myocardial infarction1 year
Incident atrial fibrillation1 year
Incident renal insufficiency1 year

Other

MeasureTime frameDescription
Recurrent hospitalizations during study period1 year
Invasive procedures1 year
Prescription of proven therapies during hospitalization among ideal patientsDuration of hospitalization, average of 10 daysPrescription of proven therapies (for HF medications, including dosage) during hospitalization among ideal patients (with indication and without contraindication)
Use of proven therapies during follow-up among ideal patients1 yearUse of proven therapies (for HF medications, including dosage) during follow-up among ideal patients (with indication and without contraindication)
Length of stay in hospital1 yearFor index hospitalization and accumulative during follow-up
Length of stay in ICU/CCU for index hospitalizationDuration of hospitalization, average of 10 days

Countries

China

Contacts

Primary ContactJing Li, MD, PhD
jing.li@fwoxford.org+86 (10) 6086 6077
Backup ContactYuan Yu, MD
yuan.yu@fwoxford.org+86 17801013954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026