Risk Evaluation and Management in Heart Failure

Recruiting

• Conditions: Heart Failure; Risk Factor, Cardiovascular

• Registration Number: NCT02998788
• Lead Sponsor: Ruijin Hospital

Brief Summary

This is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis.

Detailed Description

Heart failure is the main cause of cardiovascular death. The primary goal of this study is to estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption, sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and circulating biomarkers with heart failure prognosis. Another goal is to improve the health status and reduce cardiovascular events and death for heart failure patients via patient education, disease monitoring and medication titration. This study planned to consecutively enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will be followed up for at least 5 years. The study endpoints, all-cause mortality and cardiovascular events, will be identified by directly contacting participants during the follow-up surveys, checking pertinent medical records and discharge lists from the hospitals, or checking death certificates from local vital statistics offices. The Cox proportional hazard model will be used to estimate the risk factors for health outcomes in heart failure patients.

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-12
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• aged 18 and above

• inpatient with one of the following clinical situations:

  • congestive heart failure (pulmonary edema,pulmonary congestion or peripheral edema)
  • cardiogenic shock
  • Insufficient high output cardiac

• with impaired cardiac function diagnosed by echocardiography

• able to provide informed consent

Exclusion Criteria

• expressed refusal to participate in the baseline investigation or follow-up visits Severe co-morbidity associated with a reduction in life expectancy of less than 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	10 years
A composite of cardiovascular events	10 years	A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death

Secondary Outcome Measures

Name	Time	Method
myocardial infarction	10 years
rehospitalization due to heart failure	10 years
revascularization	10 years
stroke	10 years
cardiovascular death	10 years

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China