Obesity-related heart failure
Conditions
Interventions
Control group:Usual heart failure dietary education
Time-restricted eating group:Time-restricted eating
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-60; 2. Body Mass Index (BMI) >= 28 kg/m^2; 3. Previously diagnosed with chronic heart failure according to the "China Heart Failure Diagnosis and Treatment Guidelines 2024" (NYHA class II-III); and in the month prior to enrollment, echocardiography shows clear cardiac enlargement (meeting any one of the following): left ventricular end-diastolic diameter (LVEDD) >= 55 mm for men, >= 50 mm for women, or left atrial anterior-posterior diameter (LA) >= 33 mm, or 6-minute walk distance = 10 hours and able to cooperate with time-restricted eating intervention, food photo uploads, and diet recording; 6. Able to complete the full 12-week follow-up, measurements, and all quality control requirements according to the study protocol; 7. Willing to participate in this study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary or drug-induced obesity (such as obesity caused by abnormalities in the gonadal, adrenal, or thyroid axes, or caused by medications like glucocorticoids) 2. Previously diagnosed with diabetic cardiomyopathy or hypertensive cardiomyopathy 3. Patients who started GLP-1RA treatment, adjusted dosage/formulations, or stopped the drug within 3 months before enrollment, or those planning to adjust dosage, switch drugs, or stop GLP-1RA after enrollment, or patients using GLP-1RA off-label or inappropriately 4. Exclude patients whose obesity onset was later than ASCVD (history of myocardial infarction, ACS within 1 year, stroke or TIA, symptomatic peripheral vascular disease) and related comorbidities (like hypertension, diabetes, valve disease) with a time of diagnosis =1 year 5. Active liver disease (defined as any known infectious, tumor-related, or metabolic liver condition, or unexplained ALT or AST elevation >2 × ULN at screening) 6. Difficult-to-control hypertension: defined as systolic =180 mmHg or diastolic =110 mmHg despite receiving antihypertensive treatment before randomization 7. Chronic kidney disease with estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m² using the CKD-EPI formula 8. NYHA class IV heart failure or a known left ventricular ejection fraction <25% recently 9. Clinically significant arrhythmias that couldn’t be controlled by medication or ablation within 3 months before randomization 10. Acute or severe systemic infection, or any of the following: hematologic diseases, autoimmune disorders, malignancies, psychiatric disorders, or other serious or unstable health conditions affecting the study 11. Planning surgical treatment within the next 6 months 12. Women who are pregnant, breastfeeding, trying to conceive, or planning to get pregnant during the study 13. Alcohol or drug addiction 14. Currently participating in other clinical studies or unable to follow a time-restricted eating plan 15. Any condition deemed unsuitable for participation by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition;Echocardiographic parameters;Feasibility of time-restricted eating;Fasting blood glucose;Kansas City Cardiomyopathy Questionnaire score; | — |
Countries
China
Contacts
Public ContactWu Yue
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed