REM-HF: Risk Evaluation and Management in Heart Failure

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02998788
Collaborator
(none)
1,000
1
126
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Evaluation and Management in Heart Failure
    Study Start Date :
    Jun 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [10 years]

    2. 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

    1. myocardial infarction [10 years]

    2. revascularization [10 years]

    3. stroke [10 years]

    4. rehospitalization due to heart failure [10 years]

    5. cardiovascular death [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    • Principal Investigator: Wei Jin, Professor, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Jin, Professor,Department of Cardiology, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT02998788
    Other Study ID Numbers:
    • RJ-81600198
    First Posted:
    Dec 20, 2016
    Last Update Posted:
    Dec 20, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Wei Jin, Professor,Department of Cardiology, Ruijin Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 20, 2016