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Heart FailureIDEAL-HFNCT06455878

Mobile Applet for Weight Management in Obese Heart Failure Patients

A study testing Full usage of diet management app group and with the full usage of an intelligent weight scale and Limited usage of diet management app group and with the limited usage of an intelligent weight scale in people with Heart Failure and Overweight and Obesity, run by Heart Health Research Center at 26 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure, Overweight and Obesity, Weight Loss
What is being tested?
Full usage of diet management app group and with the full usage of an intelligent weight scale and Limited usage of diet management app group and with the limited usage of an intelligent weight scale
Could I receive a placebo?
No, everyone receives an active treatment
How many people
830 participants
Where
26 sitesChina
Study dates
6 Jun 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yangyang Zhao contact

+8618513340674

zhao.yangyang@hhresearch.cn

26 sites in 1 country

China26 sites, 26 recruiting

  • Xiu Yan Manchu Autonomous County Central People's Hospital

    Anshan, Liaoning

    Recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100009

    Recruiting

  • Beijing Chuiyangliu Hospital

    Beijing

    Not yet recruiting

  • Beijing Fangshan District First Hospital

    Beijing

    Recruiting

  • Emergency General Hospital

    Beijing

    Not yet recruiting

  • Qin Yuan County People's Hospital

    Changzhi, Shanxi

    Recruiting

  • Tiemei General Hospital of Liaoning Health Industry Group

    Diaobingshancun, Liaoning

    Not yet recruiting

  • Guangzhou Red Cross Hospital

    Guangzhou, Guangdong

    Recruiting

  • Jixi City People's Hospital

    Jixi, Heilongjiang

    Recruiting

  • Kaifeng Central Hospital

    Kaifeng

    Not yet recruiting

  • Langfang People's Hospital

    Langfang, Hebei

    Recruiting

  • Luoyang No.6 People's Hospital

    Luoyang, Henan

    Recruiting

  • Ruyang County People's Hospital

    Luoyang, Henan

    Recruiting

  • Pingdu People's Hospital

    Pingdu, Shandong

    Recruiting

  • Ningling County People's Hospital

    Shangqiu, Henan

    Recruiting

  • Yongcheng People's Hospital

    Shangqiu, Henan

    Recruiting

  • Shenyang Tenth Hospital

    Shenyang, Liaoning

    Recruiting

  • Taian First Hospital

    Taian, Shandong

    Recruiting

  • Yuhuan Second People's Hospital

    Taizhou, Zhejiang

    Not yet recruiting

  • Tongliao People's Hospital

    Tongliao, Inner Mongolia

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, The Xinjiang Uygur Autonomous Region

    Recruiting

  • Weihai Central Hospital

    Weihai, Shandong

    Not yet recruiting

  • Xian Red Cross Hospital

    Xian, Shanxi

    Recruiting

  • Shangcheng County People's Hospital

    Xinyang, Henan

    Recruiting

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

    Yulin, Shanxi

    Recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan

    Not yet recruiting

Other trials in China

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
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
Medical subject headings
Heart Failure, Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 scaleBehavioural

    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 groups in NCT06455878
Study groupRoleWhat they receive
Full usage of diet management app group and with the full usage of an intelligent weight scaleExperimentalFull 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).
Receives: 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 scaleActive comparatorLimited 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).
Receives: Behavioral: Limited usage of diet management app group and with the limited usage of an intelligent weight scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Randomization through 1 year

Secondary outcomes (6)

  1. Cardiovascular death within 1 year

    Events of Cardiovascular death happened

    Measured: From randomization to 1 year

  2. Number of heart failure hospitalizations within 1 year

    Number of hospitalizations due to heart failure through 1 year

    Measured: From randomization to 1 year

  3. Time of the first hospitalization for heart failure within 1 year

    The time of the first hospitalization in days for heart failure within 1 year

    Measured: From randomization to 1 year

  4. All cause death within 1 year

    Death from any cause through 1 year

    Measured: From randomization to 1 year

  5. Heart failure-related quality of life (KCCQ)

    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).

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

  6. Percentage change of weight

    Percentage change of weight compared with baseline

    Measured: From randomization to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start6 Jun 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
830 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455878
Sponsor's protocol ID
Study2024-1
Acronym
IDEAL-HF
Status last verified
Jun 2025
First submitted
3 Jun 2024
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lam CSP, Gamble GD, Ling LH, Sim D, Leong KTG, Yeo PSD, Ong HY, Jaufeerally F, Ng TP, Cameron VA, Poppe K, Lund M, Devlin G, Troughton R, Richards AM, Doughty RN. Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study. Eur Heart J. 2018 May 21;39(20):1770-1780. doi: 10.1093/eurheartj/ehy005.

    PubMed 29390051

  • Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.

    PubMed 32483830

  • Aurigemma GP, de Simone G, Fitzgibbons TP. Cardiac remodeling in obesity. Circ Cardiovasc Imaging. 2013 Jan 1;6(1):142-52. doi: 10.1161/CIRCIMAGING.111.964627. No abstract available.

    PubMed 23322729

  • Wang H, Li YY, Chai K, Zhang W, Li XL, Dong YG, Zhou JM, Huo Y, Yang JF. [Contemporary epidemiology and treatment of hospitalized heart failure patients in real clinical practice in China]. Zhonghua Xin Xue Guan Bing Za Zhi. 2019 Nov 24;47(11):865-874. doi: 10.3760/cma.j.issn.0253-3758.2019.11.004. Chinese.

    PubMed 31744275

  • Borlaug BA, Jensen MD, Kitzman DW, Lam CSP, Obokata M, Rider OJ. Obesity and heart failure with preserved ejection fraction: new insights and pathophysiological targets. Cardiovasc Res. 2023 Feb 3;118(18):3434-3450. doi: 10.1093/cvr/cvac120.

    PubMed 35880317

  • Koliaki C, Liatis S, Kokkinos A. Obesity and cardiovascular disease: revisiting an old relationship. Metabolism. 2019 Mar;92:98-107. doi: 10.1016/j.metabol.2018.10.011. Epub 2018 Nov 3.

    PubMed 30399375

  • Shariq OA, McKenzie TJ. Obesity-related hypertension: a review of pathophysiology, management, and the role of metabolic surgery. Gland Surg. 2020 Feb;9(1):80-93. doi: 10.21037/gs.2019.12.03.

    PubMed 32206601

  • Cao E, Watt MJ, Nowell CJ, Quach T, Simpson JS, De Melo Ferreira V, Agarwal S, Chu H, Srivastava A, Anderson D, Gracia G, Lam A, Segal G, Hong J, Hu L, Phang KL, Escott ABJ, Windsor JA, Phillips ARJ, Creek DJ, Harvey NL, Porter CJH, Trevaskis NL. Mesenteric lymphatic dysfunction promotes insulin resistance and represents a potential treatment target in obesity. Nat Metab. 2021 Sep;3(9):1175-1188. doi: 10.1038/s42255-021-00457-w. Epub 2021 Sep 20.

    PubMed 34545251

  • Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure. N Engl J Med. 2002 Aug 1;347(5):305-13. doi: 10.1056/NEJMoa020245.

    PubMed 12151467

  • Ho JE, Lyass A, Lee DS, Vasan RS, Kannel WB, Larson MG, Levy D. Predictors of new-onset heart failure: differences in preserved versus reduced ejection fraction. Circ Heart Fail. 2013 Mar;6(2):279-86. doi: 10.1161/CIRCHEARTFAILURE.112.972828. Epub 2012 Dec 27.

    PubMed 23271790

  • Brouwers FP, de Boer RA, van der Harst P, Voors AA, Gansevoort RT, Bakker SJ, Hillege HL, van Veldhuisen DJ, van Gilst WH. Incidence and epidemiology of new onset heart failure with preserved vs. reduced ejection fraction in a community-based cohort: 11-year follow-up of PREVEND. Eur Heart J. 2013 May;34(19):1424-31. doi: 10.1093/eurheartj/eht066. Epub 2013 Mar 6.

    PubMed 23470495

  • Pandey A, LaMonte M, Klein L, Ayers C, Psaty BM, Eaton CB, Allen NB, de Lemos JA, Carnethon M, Greenland P, Berry JD. Relationship Between Physical Activity, Body Mass Index, and Risk of Heart Failure. J Am Coll Cardiol. 2017 Mar 7;69(9):1129-1142. doi: 10.1016/j.jacc.2016.11.081.

    PubMed 28254175

  • Horwich TB, Fonarow GC, Clark AL. Obesity and the Obesity Paradox in Heart Failure. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):151-156. doi: 10.1016/j.pcad.2018.05.005. Epub 2018 May 28.

    PubMed 29852198

  • Butt JH, Petrie MC, Jhund PS, Sattar N, Desai AS, Kober L, Rouleau JL, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJV. Anthropometric measures and adverse outcomes in heart failure with reduced ejection fraction: revisiting the obesity paradox. Eur Heart J. 2023 Apr 1;44(13):1136-1153. doi: 10.1093/eurheartj/ehad083.

    PubMed 36944496

  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e876-e894. doi: 10.1161/CIR.0000000000001062. Epub 2022 Apr 1.

    PubMed 35363500

Questions about this trial

What is this clinical trial studying?

A study testing Full usage of diet management app group and with the full usage of an intelligent weight scale and Limited usage of diet management app group and with the limited usage of an intelligent weight scale in people with Heart Failure and Overweight and Obesity, run by Heart Health Research Center at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yangyang Zhao (+8618513340674, zhao.yangyang@hhresearch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical Composite Outcomes (time frame: Randomization through 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455878, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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