China PEACE 5p-HF Study

• Conditions: Heart Failure

• Registration Number: NCT02878811
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-20
• Study First Posted: 2016-08-25
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-11
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xinxiang Central Hospital; 🇨🇳 Xinxiang, China