Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure

NCT ID: NCT03951311

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2026-12-31

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.

Conditions

Heart Failure; Metabolic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhijun Wu

Principal Investigator of department of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhijun Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhijun Wu, MD

Role: CONTACT

totito19822005@126.com

008613818908053

Facility Contacts

Zhijun Wu, MD

Role: primary

totito19822005@126.com

008613818908053

References

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.

Reference Type: DERIVED

PMID: 35501092 (View on PubMed)

Other Identifiers

RJ-20172004

Identifier Type: -

Identifier Source: org_study_id