Mobile Applet for Weight Management in Obese Heart Failure Patients

NCT06455878 | Recruiting DMC

• 1 other identifier: Study2024-1
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Heart Failure; Overweight and Obesity; Weight Loss; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Hierarchical Composite Outcomes

  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.

  Randomization through 1 year

Secondary Outcomes (6)

• Cardiovascular death within 1 year

  From randomization to 1 year

• Number of heart failure hospitalizations within 1 year

  From randomization to 1 year

• Time of the first hospitalization for heart failure within 1 year

  From randomization to 1 year

• All cause death within 1 year

  From randomization to 1 year

• Heart failure-related quality of life (KCCQ)

  At baseline, 3-month and 1-year follow-ups.

Study Arms (2)

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

EXPERIMENTAL

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).

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

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

ACTIVE COMPARATOR

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).

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Health Research Center: lead

Study Sites (26)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100009, China

RECRUITING

Guangzhou Red Cross Hospital

Guangzhou, Guangdong, China

RECRUITING

Langfang People's Hospital

Langfang, Hebei, China

RECRUITING

Jixi City People's Hospital

Jixi, Heilongjiang, China

RECRUITING

Luoyang No.6 People's Hospital

Luoyang, Henan, China

RECRUITING

Ruyang County People's Hospital

Luoyang, Henan, China

RECRUITING

Ningling County People's Hospital

Shangqiu, Henan, China

RECRUITING

Yongcheng People's Hospital

Shangqiu, Henan, China

RECRUITING

Shangcheng County People's Hospital

Xinyang, Henan, China

RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Tongliao People's Hospital

Tongliao, Inner Mongolia, China

RECRUITING

Xiu Yan Manchu Autonomous County Central People's Hospital

Anshan, Liaoning, China

RECRUITING

Tiemei General Hospital of Liaoning Health Industry Group

Diaobingshancun, Liaoning, China

NOT YET RECRUITING

Shenyang Tenth Hospital

Shenyang, Liaoning, China

RECRUITING

Pingdu People's Hospital

Pingdu, Shandong, China

RECRUITING

Taian First Hospital

Taian, Shandong, China

RECRUITING

Weihai Central Hospital

Weihai, Shandong, China

NOT YET RECRUITING

Qin Yuan County People's Hospital

Changzhi, Shanxi, China

RECRUITING

Xian Red Cross Hospital

Xian, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital

Yulin, Shanxi, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, The Xinjiang Uygur Autonomous Region, China

RECRUITING

Yuhuan Second People's Hospital

Taizhou, Zhejiang, China

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

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MeSH Terms

Conditions

Heart Failure; Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rong Han

  Heart Health Research Center

  STUDY DIRECTOR

Central Study Contacts

Yangyang Zhao

CONTACT

+8618513340674; zhao.yangyang@hhresearch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 12, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (26)