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NCT Number: NCT03951311

Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Zhijun Wu, MD

CONTACT

[email protected]

008613818908053

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 14 years or older;
  • typical symptoms of heart failure according to the Framingham criteria;
  • 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

  • age <14 years or ≥90 years;
  • pregnancy;
  • cancer with a life expectancy of less than one year;
  • participation in other trials;
  • endocarditis, pericardial diseases, or congenital heart diseases;
  • heart failure secondary to non-cardiac diseases (e.g., pulmonary heart disease, infection, infiltration, metabolic derangements, severe anemia, sepsis, and arteriovenous fistula);
  • lack of informed consent;
  • refusal of the drug treatment or intervention recommended by the guidelines.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhijun Wu, MD

CONTACT

[email protected]

008613818908053

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure

Acronym: MALD-HF

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 15, 2019
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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