NCT06455878Recruiting
Mobile Applet for Weight Management in Obese Heart Failure Patients
The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 830 (estimated)
- First submitted
- 3 Jun 2024
- Start date
- 6 Jun 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Heart Health Research Center
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06455878
What you commit to
- Study type: Interventional
- Planned participants: 830
- From 6 Jun 2024 to the primary completion date, 30 Jun 2026
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of weight-loss medications or planned bariatric surgery;
- Concurrent participation in another interventional clinical study.
Other illness
- 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);
- Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
- 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);
Lab values
- 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;
Other
- Alcohol or substance abuse;
- Planned hospitalization during the trial period;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiu Yan Manchu Autonomous County Central People's Hospital Coordinator of this site? Confirm its status | Anshan | China | Recruiting |
| Emergency General Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Fangshan District First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Chuiyangliu Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Qin Yuan County People's Hospital Coordinator of this site? Confirm its status | Changzhi | China | Recruiting |
| Tiemei General Hospital of Liaoning Health Industry Group Coordinator of this site? Confirm its status | Diaobingshancun | China | Not yet recruiting |
| Guangzhou Red Cross Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Jixi City People's Hospital Coordinator of this site? Confirm its status | Jixi | China | Recruiting |
| Kaifeng Central Hospital Coordinator of this site? Confirm its status | Kaifeng | China | Not yet recruiting |
| Langfang People's Hospital Coordinator of this site? Confirm its status | Langfang | China | Recruiting |
| Ruyang County People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Luoyang No.6 People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Pingdu People's Hospital Coordinator of this site? Confirm its status | Pingdu | China | Recruiting |
| Ningling County People's Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Recruiting |
| Yongcheng People's Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Recruiting |
| Shenyang Tenth Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Taian First Hospital Coordinator of this site? Confirm its status | Taian | China | Recruiting |
| Yuhuan Second People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Not yet recruiting |
| Tongliao People's Hospital Coordinator of this site? Confirm its status | Tongliao | China | Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Weihai Central Hospital Coordinator of this site? Confirm its status | Weihai | China | Not yet recruiting |
| Xian Red Cross Hospital Coordinator of this site? Confirm its status | Xian | China | Recruiting |
| Shangcheng County People's Hospital Coordinator of this site? Confirm its status | Xinyang | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital Coordinator of this site? Confirm its status | Yulin | China | Recruiting |
| Henan Provincial Chest Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.