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NCT Number: NCT06455878

Mobile Applet for Weight Management in Obese Heart Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cardiovascular death within 1 year

    Time frame: From randomization to 1 year

    Events of Cardiovascular death happened

  2. 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

  3. 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

  4. All cause death within 1 year

    Time frame: From randomization to 1 year

    Death from any cause through 1 year

  5. 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).

  6. Percentage change of weight

    Time frame: From randomization to 1 year

    Percentage change of weight compared with baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Yangyang Zhao

CONTACT

[email protected]

+8618513340674

Sponsors and collaborators

Lead sponsor

Heart Health Research Center

Other

Registry information

Official study title

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

Acronym: IDEAL-HF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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