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

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ClinicalTrials.gov Identifier: NCT03951311
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Zhijun Wu, Ruijin Hospital

Study Description
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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 disease
Heart Failure Metabolic Disease

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF [ Time Frame: 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 [ Time Frame: 5 years ]
    sudden death or deaths due to CVD events

  2. hospitalization due to worsening HF [ Time Frame: 5 years ]
    the adjudicated hospitalizations due to subjectively and objectively worsening HF


Biospecimen Retention:   Samples With DNA
Fasting venous blood samples were drawn and transfused into vacuum tubes containing EDTA after admission. These samples were stored and further analyzed in the Central Laboratory of Ruijin Hospital.

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients diagnosed with heart failure who had impaired cardiac function or abnormal cardiac structure with elevated blood BNP concentrations
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951311


Contacts
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Contact: Zhijun Wu, MD 008613818908053 totito19822005@126.com

Locations
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China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Zhijun Wu, MD    008613818908053    totito19822005@126.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Zhijun Wu, MD Ruijin Hospital
More Information
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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    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases