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Recruiting NCT06455878

Mobile Applet for Weight Management in Obese Heart Failure Patients

Trial Parameters

Condition Heart Failure
Sponsor Heart Health Research Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 830
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-06
Completion 2026-06-30
Interventions
Full usage of diet management app group and with the full usage of an intelligent weight scaleLimited usage of diet management app group and with the limited usage of an intelligent weight scale

Brief 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 Criteria

Inclusion Criteria: 1. Age ≥18 years; 2. Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III; 3. 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; 4. Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period; 5. History of heart failure hospitalization within the past 6 months; 6. Signed informed consent. Exclusion Criteria: 1. 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); 2. Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis); 3. Moderate or severe anemia (hemoglobin \[Hb\] \<90 g/L); 4. Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²) or ongoing dialysis; 5.

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