Mobile Applet for Weight Management in Obese Heart Failure Patients (IDEAL-HF)

June 24, 2025 updated by: Heart Health Research Center

The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is one of the major risk factors for heart failure. Current guidelines for heart failure emphasize that severe obesity is associated with a poor prognosis in patients with heart failure, but there are no recommended effective interventions.

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.

Study Type

Interventional

Enrollment (Estimated)

830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Chuiyangliu Hospital
      • Beijing, China
        • Recruiting
        • Beijing Fangshan District First Hospital
      • Beijing, China
        • Not yet recruiting
        • Emergency General Hospital
      • Kaifeng, China
        • Not yet recruiting
        • Kaifeng Central Hospital
    • Beijing
      • Beijing, Beijing, China, 100009
        • Recruiting
        • Beijing Anzhen Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Red Cross Hospital
    • Hebei
      • Langfang, Hebei, China
        • Recruiting
        • Langfang People's Hospital
    • Heilongjiang
      • Jixi, Heilongjiang, China
        • Recruiting
        • Jixi City People's Hospital
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • Ruyang County People's Hospital
      • Luoyang, Henan, China
        • Recruiting
        • Luoyang No.6 People's Hospital
      • Shangqiu, Henan, China
        • Recruiting
        • Yongcheng People's Hospital
      • Shangqiu, Henan, China
        • Recruiting
        • Ningling County People's Hospital
      • Xinyang, Henan, China
        • Recruiting
        • Shangcheng County People's Hospital
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial Chest Hospital
    • Inner Mongolia
      • Tongliao, Inner Mongolia, China
        • Recruiting
        • Tongliao People's Hospital
    • Liaoning
      • Anshan, Liaoning, China
        • Recruiting
        • Xiu Yan Manchu Autonomous County Central People's Hospital
      • Diaobingshan, Liaoning, China
        • Not yet recruiting
        • Tiemei General Hospital of Liaoning Health Industry Group
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Tenth Hospital
    • Shandong
      • Pingdu, Shandong, China
        • Recruiting
        • Pingdu People's Hospital
      • Taian, Shandong, China
        • Recruiting
        • Taian First Hospital
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Central Hospital
    • Shanxi
      • Changzhi, Shanxi, China
        • Recruiting
        • Qin Yuan County People's Hospital
      • Xian, Shanxi, China
        • Recruiting
        • Xian Red Cross Hospital
      • Yulin, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital
    • Zhejiang
      • Taizhou, Zhejiang, China
        • Not yet recruiting
        • Yuhuan Second People's Hospital
    • the Xinjiang Uygur Autonomous Region
      • Urumqi, the Xinjiang Uygur Autonomous Region, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: 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.
Active Comparator: 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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hierarchical Composite Outcomes
Time Frame: 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.
Randomization through 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death within 1 year
Time Frame: From randomization to 1 year
Events of Cardiovascular death happened
From randomization to 1 year
Number of heart failure hospitalizations within 1 year
Time Frame: From randomization to 1 year
Number of hospitalizations due to heart failure through 1 year
From randomization to 1 year
Time of the first hospitalization for heart failure within 1 year
Time Frame: From randomization to 1 year
The time of the first hospitalization in days for heart failure within 1 year
From randomization to 1 year
All cause death within 1 year
Time Frame: From randomization to 1 year
Death from any cause through 1 year
From randomization to 1 year
Heart failure-related quality of life (KCCQ)
Time Frame: At baseline, 3-month and 1-year follow-ups.
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).
At baseline, 3-month and 1-year follow-ups.
Percentage change of weight
Time Frame: From randomization to 1 year
Percentage change of weight compared with baseline
From randomization to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Health Research Center

Investigators

  • Study Director: Rong Han, Heart Health Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study2024-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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