Risk Evaluation and Management in Heart Failure

Heart Failure Clinical Trial

— REM-HF  

Official title:

Risk Evaluation and Management in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998788
• Other study ID #: RJ-81600198
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2016
• Last updated: December 19, 2016
• Start date: June 2016
• Est. completion date: December 2026

Study information

• Verified date: December 2016
• Source: Ruijin Hospital
• Contact: Zhijun Wu, MD
• Phone: 008613818908053
• Email: totito19822005[@]126.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Risk Factor, Cardiovascular

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		10 years	Yes
Primary	A composite of cardiovascular events	A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death	10 years	Yes
Secondary	myocardial infarction		10 years	Yes
Secondary	revascularization		10 years	Yes
Secondary	stroke		10 years	Yes
Secondary	rehospitalization due to heart failure		10 years	Yes
Secondary	cardiovascular death		10 years	Yes