Impact of Metabolic Abnormalities and Lifestyle on Heart Failure
Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
Ruijin Hospital · NCT03951311
This study is trying to see how things like diet, exercise, and metabolic health affect the long-term outcomes for people with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 14 Years to 90 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03951311 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how metabolic abnormalities, lifestyle behaviors, and dietary patterns affect the prognosis of heart failure in patients. It plans to enroll 1,500 participants aged 14 years and older who have heart failure with reduced or mid-range ejection fraction. Participants will be followed for five years, during which data on their metabolic health, lifestyle choices, and diet will be collected through standardized questionnaires. The study will also track major adverse cardiac events through medical records and discharge lists.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 years or older with heart failure and an ejection fraction of less than 50%.
Not a fit: Patients with heart failure due to non-cardiac diseases or those with a life expectancy of less than one year due to cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how lifestyle and metabolic factors influence heart failure outcomes, potentially leading to improved management strategies.
How similar studies have performed: Other studies have shown that lifestyle and metabolic factors significantly impact heart failure outcomes, suggesting this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Zhijun Wu, MD — Ruijin Hospital
- Study coordinator: Zhijun Wu, MD
- Email: totito19822005@126.com
- Phone: 008613818908053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Metabolic Disease