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Risk Evaluation and Management in Heart Failure

NCT ID: NCT02998788

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure Risk Factor, Cardiovascular

Keywords

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heart failure risk factor cardiovascular disease lifestyle behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Jin

Professor,Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Jin, Professor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhijun Wu, MD

Role: CONTACT

Phone: 008613818908053

Email: [email protected]

Facility Contacts

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Zhijun Wu, MD

Role: primary

Other Identifiers

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RJ-81600198

Identifier Type: -

Identifier Source: org_study_id