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.
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;
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;
Parallel
Full usage of diet management app group and with the full usage of an intelligent weight scale
BehavioralSubjects 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.
Limited usage of diet management app group and with the limited usage of an intelligent weight scale
BehavioralSubjects 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.
Hierarchical Composite Outcomes
Patients experience "all-cause death, number of heart failure hospitalizations, time for the first heart failure hospitalization in days, assessment of heart failure frailty, heart failure-related quality of life, and percentage change of weight" by 1 year compared with baseline in the hierarchical composite endpoint analysis. Hierarchical composite outcome measure include: Death from any cause through 1 year; Number of hospitalizations due to heart failure through 1 year; Time for the first heart failure hospitalization in days through 1 year; Assessment of heart failure frailty (Fried Frailty Scale: score from 0 to 5, score ≥ 3 means frail, 1-2 means intermediate or pre-frail, 0 means robust); Heart failure-related quality of life (Kansas City Cardiomyopathy Questionnaire, KCCQ: score from 0 to 100, score 0-24 means quality of life is very poor to poor, 25-49 means poor to fair, 50-74 means fair to good, 75-100 means good to excellent); Percentage change of weight.
Cardiovascular death within 1 year
Events of Cardiovascular death happened
Number of heart failure hospitalizations within 1 year
Number of hospitalizations due to heart failure through 1 year
Time of the first hospitalization for heart failure within 1 year
The time of the first hospitalization in days for heart failure within 1 year
All cause death within 1 year
Death from any cause through 1 year
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