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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Metabolic Disease

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Zhijun Wu, MD; Phone Number: 008613818908053; Email: totito19822005@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Zhijun Wu, MD; Phone Number: 008613818908053; Email: totito19822005@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular mortality	sudden death or deaths due to CVD events	5 years
hospitalization due to worsening HF	the adjudicated hospitalizations due to subjectively and objectively worsening HF	5 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Zhijun Wu, MD, Ruijin Hospital

Publications and helpful links

General Publications

• Jin Y, Huang H, Zhou Q, Dong F, Lu L, Gao X, Wu Z. Prospective assessing metabolic abnormalities, lifestyle and dietary pattern in a Chinese population with heart failure: the MALD-HF study protocol. BMJ Open. 2022 May 2;12(5):e049225. doi: 10.1136/bmjopen-2021-049225.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Metabolic Diseases
• Other Study ID Numbers: RJ-20172004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No