China PEACE 5p-HF Study | NCT02878811

Studies
China PEACE 5p-HF Study

NCT02878811

Sponsor

China National Center for Cardiovascular Diseases

Status

Unknown status

Last Update Posted

Dec 11, 2017Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Observational study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Aug 16, 2016

First Submission Date that Met QC Criteria

Aug 20, 2016

First Posted Date

Aug 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2017

Last Update Posted Date

Dec 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study	Other	This is a non-interventional study, patients receive their usual treatment as determined by the physician.

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Death	Cardiovascular death and non-cardiovascular death	1 year
Rehospitalization	HF-related and non HF-related	1 year

Other Outcomes

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Li, MD, PhD	Contact	+86 (10) 6086 6077		jing.li@fwoxford.org
Yuan Yu, MD	Contact	+86 17801013954		yuan.yu@fwoxford.org

Overall Officials

Name	Affiliation	Role
Jing Li, MD, PhD	China National Center for Cardiovascular Disease	Principal Investigator
Harlan M Krumholz, MD, SM	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinxiang Central Hospital	Recruiting	Xinxiang			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40693625	Derived	Li J, Lei L, Wang W, Li Y, Yu Y, Pu B, Peng Y, Huo X, Zhang L. Patient-reported health status vs . N-terminal pro-B-type natriuretic peptide levels in patients with acute heart failure. Chin Med J (Engl). 2025 Nov 20;138(22):2955-2962. doi: 10.1097/CM9.0000000000003555. Epub 2025 Jul 22.
38290578	Derived

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D008722	Methods
D008919	Investigative Techniques