Mobile Applet for Weight Management in Obese Heart Failure Patients

NCT06455878 · tracked via the Priya Life Science China tracker

Sponsor

Heart Health Research Center

Phase

Not applicable

Started

2024-06-06

Last updated

2025-06-27

Condition(s) studied

Heart FailureOverweight and ObesityWeight LossHeart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Hierarchical Composite Outcomes — Randomization 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 means fair to good, 75-100 means good to excellent); Percentage change of weight.

Trial sites (26)

Facility	City	Region	Status
Beijing Anzhen Hospital	Beijing	Beijing Municipality	Recruiting
Guangzhou Red Cross Hospital	Guangzhou	Guangdong	Recruiting
Langfang People's Hospital	Langfang	Hebei	Recruiting
Jixi City People's Hospital	Jixi	Heilongjiang	Recruiting
Luoyang No.6 People's Hospital	Luoyang	Henan	Recruiting
Ruyang County People's Hospital	Luoyang	Henan	Recruiting
Ningling County People's Hospital	Shangqiu	Henan	Recruiting
Yongcheng People's Hospital	Shangqiu	Henan	Recruiting
Shangcheng County People's Hospital	Xinyang	Henan	Recruiting
Henan Provincial Chest Hospital	Zhengzhou	Henan	Not Yet Recruiting
Tongliao People's Hospital	Tongliao	Inner Mongolia	Recruiting
Xiu Yan Manchu Autonomous County Central People's Hospital	Anshan	Liaoning	Recruiting
Tiemei General Hospital of Liaoning Health Industry Group	Diaobingshancun	Liaoning	Not Yet Recruiting
Shenyang Tenth Hospital	Shenyang	Liaoning	Recruiting
Pingdu People's Hospital	Pingdu	Shandong	Recruiting
Taian First Hospital	Taian	Shandong	Recruiting
Weihai Central Hospital	Weihai	Shandong	Not Yet Recruiting
Qin Yuan County People's Hospital	Changzhi	Shanxi	Recruiting
Xian Red Cross Hospital	Xian	Shanxi	Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital	Yulin	Shanxi	Recruiting
The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	The Xinjiang Uygur Autonomous Region	Recruiting
Yuhuan Second People's Hospital	Taizhou	Zhejiang	Not Yet Recruiting
Beijing Chuiyangliu Hospital	Beijing	China	Not Yet Recruiting
Beijing Fangshan District First Hospital	Beijing	China	Recruiting
Emergency General Hospital	Beijing	China	Not Yet Recruiting
Kaifeng Central Hospital	Kaifeng	China	Not Yet Recruiting

More Heart Health Research Center trials in China

Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients Recruiting

Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial Starting soon

Other trials for the same condition

Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients Recruiting

Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients Starting soon

HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management Recruiting

Community Exercise Treating Effect on Cardiopulmonary Disease Patients Recruiting

Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06455878 on ClinicalTrials.gov ↗ ← All trials in China