MALD-HF: Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03951311
Collaborator
(none)
1,500
Enrollment
1
Location
127
Anticipated Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Metabolic abnormalities (e.g., hypertension, diabetes mellitus, dyslipidemia, and obesity) and unhealthy lifestyle behaviors (e.g., smoking and drinking habits, sedentary behavior, sleep disorder and physical inactivity) and unhealthy diet (e.g., high sugar and high fat) are major risk factors for cardiovascular diseases mobility and mortality. The investigators sought to estimate the impact of metabolic abnormalities, lifestyle behavior and diet pattern on prognosis of heart failure. This study planned to consecutively enroll 1,500 participants with heart failure with reduced ejection fraction and heart failure with mid-range ejection fraction fulfilling the inclusion criteria. Each heart failure survivors will be followed up for 5 years. Information on metabolic diseases, lifestyle and diet pattern were obtained through standardized questionnaire. The major adverse cardiac events will be identified by reviewing pertinent medical records and discharge lists from the hospitals, or official death certificates collected at local death registration centers, or directly contacting participants' family. The Cox proportional hazard model will be used to assess the association between metabolic risk factors and lifestyle and diet habits and health outcomes in heart failure patients.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
    Actual Study Start Date :
    Jun 1, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF [5 years]

      An independent committee of experts including three physicians reviews all the death certificates and medical records for adjudicating the death cases and all suspected CVD cases biennially from the index episode, via telephone contacting patients' family members or reviewing medical records and the Hospital Discharge Register data.

    Secondary Outcome Measures

    1. cardiovascular mortality [5 years]

      sudden death or deaths due to CVD events

    2. hospitalization due to worsening HF [5 years]

      the adjudicated hospitalizations due to subjectively and objectively worsening HF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. aged 14 years or older;

    2. typical symptoms of heart failure according to the Framingham criteria;

    3. left ventricular ejection fraction (LVEF) <50%, demonstrated by echocardiography or cardiac magnetic resonance, which include either patients with mid-range EF (HFmEF) or with reduced EF (HFrEF) with relevant structural and functional cardiac changes and/or elevated N-terminal pro-brain B-type natriuretic peptide (pro-BNP) (e.g., ≥400 pg/mL).

    Exclusion Criteria:
    1. age <14 years or ≥90 years;

    2. pregnancy;

    3. cancer with a life expectancy of less than one year;

    4. participation in other trials;

    5. endocarditis, pericardial diseases, or congenital heart diseases;

    6. heart failure secondary to non-cardiac diseases (e.g., pulmonary heart disease, infection, infiltration, metabolic derangements, severe anemia, sepsis, and arteriovenous fistula);

    7. lack of informed consent;

    8. refusal of the drug treatment or intervention recommended by the guidelines.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Ruijin Hospital, Shanghai Jiaotong University School of MedicineShanghaiShanghaiChina200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    • Principal Investigator: Zhijun Wu, MD, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhijun Wu, Principal Investigator of department of cardiology, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT03951311
    Other Study ID Numbers:
    • RJ-20172004
    First Posted:
    May 15, 2019
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021