Mobile Applet for Weight Management in Obese Heart Failure Patients
The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial
Heart Health Research Center
830 participants
Jun 6, 2024
INTERVENTIONAL
Conditions
Summary
The objective of this clinical trial is to investigate the effect of weight reduction through a diet management application and an intelligent weight scale on a composite cardiovascular endpoint in obese patients with heart failure. The main questions are: Does the use of a diet management APP and intelligent weight scale reduce 1-year all-cause mortality, heart failure hospitalization, and first heart failure hospital stay? Does the use of a diet management APP and intelligent weight scale improve the outcomes of assessment of heart failure frailty and quality of life for heart failure? Researchers will compare using the fully functional diet management app and intelligent weight scale to using the limitedly functional app and intelligent weight scale to see if the app works to improve heart failure conditions. Participants will: Use the diet management app at every meal and the intelligent weight scale every day for 12 months, and visit the clinic at 12 months for checkups.
Eligibility
Inclusion Criteria6
- Age ≥18 years;
- Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III;
- Body mass index (BMI) ≥ 26 kg/m² or male waist-to-hip ratio (WHR=waist circumference/hip circumference) ≥ 0.9, female waist-to-hip ratio ≥ 0.85;
- Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period;
- History of heart failure hospitalization within the past 6 months;
- Signed informed consent.
Exclusion Criteria11
- End-stage heart failure (≥2 hospitalizations for heart failure in the past 3 months, intolerance to guideline-directed medical therapy (GDMT), or dependence on inotropic agents);
- Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis);
- Moderate or severe anemia (hemoglobin \[Hb\] \<90 g/L);
- Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²) or ongoing dialysis;
- Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
- Alcohol or substance abuse;
- Current use of weight-loss medications or planned bariatric surgery;
- Malignancy with an expected survival \<1 year;
- Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals);
- Planned hospitalization during the trial period;
- Concurrent participation in another interventional clinical study.
Interventions
Subjects will use the fully functional diet management application and an intelligent weight scale with full function designed for obese heart failure patients to help them losed weight and invitigate some important composite cardiovascular endpoint.
Subjects will use the limited function diet management application and an intelligent weight scale with limited function designed for obese heart failure patients as a comparator.
Locations(26)
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NCT06455878