Mobile Applet for Weight Management in Obese Heart Failure Patients
NCT ID: NCT06455878
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
830 participants
INTERVENTIONAL
2024-06-06
2026-12-31
Brief Summary
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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.
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Detailed Description
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Caloric restriction alone, increased exercise, the use of weight-loss drugs, and bariatric surgery are not appropriate for obese patients with heart failure.
Whether obese heart failure patients with reduced ejection fraction (HFrEF) can benefit from weight loss treatment has not been evaluated in randomized controlled trials so far.
This study combines caloric restriction with lifestyle management to help HFrEF patients lose weight.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Full usage of diet management app group and with the full usage of an intelligent weight scale
Full usage of the diet management app means subjects can use all functions of the application (including personal information, food record, weight record, exercise record, step count, daily dietary intake, distribution and analysis of dietary structure, and recommended foods and their structural distribution).
Full usage of the intelligent weight scale means subjects can use all functions of the scale (including the report of heart rate, total body water, body fat rate, muscle mass, protein mass, bone mass, visceral fat index, basal metabolic rate, subcutaneous fat rate, and skeletal muscle rate).
Full usage of diet management app group and with the full usage of an intelligent weight scale
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
Limited usage of the diet management app means subjects can use some functions of the application (including personal information, food record, weight record, exercise record, and step count).
Limited usage of the intelligent weight scale means subjects can use a few functions of the scale (including the weight record, lower limb impedance value, and BMI).
Limited usage of diet management app group and with the limited usage of an intelligent weight scale
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.
Interventions
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Full usage of diet management app group and with the full usage of an intelligent weight scale
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Heart Health Research Center
OTHER
Responsible Party
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Principal Investigators
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Rong Han
Role: STUDY_DIRECTOR
Heart Health Research Center
Locations
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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
Beijing Chuiyangliu Hospital
Beijing, , China
Beijing Fangshan District First Hospital
Beijing, , China
Emergency General Hospital
Beijing, , China
Kaifeng Central Hospital
Kaifeng, , China
Countries
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Central Contacts
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References
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Other Identifiers
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Study2024-1
Identifier Type: -
Identifier Source: org_study_id
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