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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02998788
Other study ID # RJ-81600198
Secondary ID
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


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
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