China PEACE 5p-HF Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878811
• Other study ID #: 2015BAI12B02-2
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: December 8, 2017
• Start date: August 2016
• Est. completion date: June 2019

Study information

• Verified date: December 2017
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, MD, PhD
• Phone: +86 (10) 6086 6077
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	Xinxiang Central Hospital	Xinxiang

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay in hospital	For index hospitalization and accumulative during follow-up	1 year
Other	Length of stay in ICU/CCU for index hospitalization		Duration of hospitalization, average of 10 days
Other	Recurrent hospitalizations during study period		1 year
Other	Invasive procedures		1 year
Other	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
Other	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
Primary	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	Death	Cardiovascular death and non-cardiovascular death	1 year
Secondary	Rehospitalization	HF-related and non HF-related	1 year
Secondary	Resuscitated sudden death		1 year
Secondary	Myocardial infarction		1 year
Secondary	Stroke		1 year
Secondary	Incident atrial fibrillation		1 year
Secondary	Incident renal insufficiency		1 year
Secondary	Quality of life (EQ-5D)		1 year
Secondary	Quality of life for HF (KCCQ-12)		1 year
Secondary	Depression (PHQ-8)		1 year
Secondary	Stress (PSS-4)		1 year
Secondary	Anxiety (GAD-2)		1 year
Secondary	Function of cognition (Mini-cog)		1 year