Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure

NCT03951311 | Recruiting DMC

• 1 other identifier: RJ-20172004
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cardiovascular mortality

  5 years

• hospitalization due to worsening HF

  5 years

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35501092 DERIVED

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.

MeSH Terms

Conditions

Heart Failure; Metabolic Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhijun Wu, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Wu, MD

CONTACT

008613818908053; totito19822005@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of department of cardiology

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: June 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

CN (1)