Mobile Applet for Weight Management in Obese Heart Failure Patients
Recruiting · NCT06455878 · Interventional (participants receive a specific treatment) · Lead sponsor: Heart Health Research Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
26 locations listed.
- Beijing Chuiyangliu Hospital - Beijing, China
- Beijing Fangshan District First Hospital - Beijing, China
- Emergency General Hospital - Beijing, China
- Kaifeng Central Hospital - Kaifeng, China
- Beijing Anzhen Hospital - Beijing, Beijing Municipality, China
- Guangzhou Red Cross Hospital - Guangzhou, Guangdong, China
- Langfang People's Hospital - Langfang, Hebei, China
- Jixi City People's Hospital - Jixi, Heilongjiang, China
- Luoyang No.6 People's Hospital - Luoyang, Henan, China
- Ruyang County People's Hospital - Luoyang, Henan, China
- Ningling County People's Hospital - Shangqiu, Henan, China
- Yongcheng People's Hospital - Shangqiu, Henan, China
- Shangcheng County People's Hospital - Xinyang, Henan, China
- Henan Provincial Chest Hospital - Zhengzhou, Henan, China
- Tongliao People's Hospital - Tongliao, Inner Mongolia, China
- Xiu Yan Manchu Autonomous County Central People's Hospital - Anshan, Liaoning, China
- Tiemei General Hospital of Liaoning Health Industry Group - Diaobingshancun, Liaoning, China
- Shenyang Tenth Hospital - Shenyang, Liaoning, China
- Pingdu People's Hospital - Pingdu, Shandong, China
- Taian First Hospital - Taian, Shandong, China
- Weihai Central Hospital - Weihai, Shandong, China
- Qin Yuan County People's Hospital - Changzhi, Shanxi, China
- Xian Red Cross Hospital - Xian, Shanxi, China
- The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital - Yulin, Shanxi, China
- The First Affiliated Hospital of Xinjiang Medical University - Ürümqi, The Xinjiang Uygur Autonomous Region, China
- Yuhuan Second People's Hospital - Taizhou, Zhejiang, China