Clinical trial

Mobile Applet for Weight Management in Obese Heart Failure Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT06455878

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionHeart Failure, Overweight and Obesity, Weight Loss, Heart Failure With Reduced Ejection Fraction

Full registry 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. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure; 6. Alcohol or substance abuse; 7. Current use of weight-loss medications or planned bariatric surgery; 8. Malignancy with an expected survival \<1 year; 9. Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals); 10. Planned hospitalization during the trial period; 11. Concurrent participation in another interventional clinical study.

Treatments and study arms

Full usage of diet management app group and with the full usage of an intelligent weight scale

Behavioral

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.

Limited usage of diet management app group and with the limited usage of an intelligent weight scale

Behavioral

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.

Primary outcomes

Hierarchical Composite OutcomesRandomization through 1 year

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…

Study locations

26 locations were listed when this page was built. The first 40 are shown.

Xiu Yan Manchu Autonomous County Central People's Hospital🇨🇳 Anshan, Liaoning, China
Beijing Anzhen Hospital🇨🇳 Beijing, Beijing Municipality, China
Beijing Chuiyangliu Hospital🇨🇳 Beijing, China
Beijing Fangshan District First Hospital🇨🇳 Beijing, China
Emergency General Hospital🇨🇳 Beijing, China
Qin Yuan County People's Hospital🇨🇳 Changzhi, Shanxi, China
Tiemei General Hospital of Liaoning Health Industry Group🇨🇳 Diaobingshancun, Liaoning, China
Guangzhou Red Cross Hospital🇨🇳 Guangzhou, Guangdong, China
Jixi City People's Hospital🇨🇳 Jixi, Heilongjiang, China
Kaifeng Central Hospital🇨🇳 Kaifeng, China
Langfang People's Hospital🇨🇳 Langfang, Hebei, China
Luoyang No.6 People's Hospital🇨🇳 Luoyang, Henan, China
Ruyang County People's Hospital🇨🇳 Luoyang, Henan, China
Pingdu People's Hospital🇨🇳 Pingdu, Shandong, China
Ningling County People's Hospital🇨🇳 Shangqiu, Henan, China
Yongcheng People's Hospital🇨🇳 Shangqiu, Henan, China
Shenyang Tenth Hospital🇨🇳 Shenyang, Liaoning, China
Taian First Hospital🇨🇳 Taian, Shandong, China
Yuhuan Second People's Hospital🇨🇳 Taizhou, Zhejiang, China
Tongliao People's Hospital🇨🇳 Tongliao, Inner Mongolia, China
Weihai Central Hospital🇨🇳 Weihai, Shandong, China
Xian Red Cross Hospital🇨🇳 Xian, Shanxi, China
Shangcheng County People's Hospital🇨🇳 Xinyang, Henan, China
The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital🇨🇳 Yulin, Shanxi, China
Henan Provincial Chest Hospital🇨🇳 Zhengzhou, Henan, China
The First Affiliated Hospital of Xinjiang Medical University🇨🇳 Ürümqi, The Xinjiang Uygur Autonomous Region, China