Mobile Applet for Weight Management in Obese Heart Failure Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Hierarchical Composite Outcomes [Срок оценки: Randomization through 1 year]

Вторичные конечные точки (6)

• Cardiovascular death within 1 year [Срок оценки: From randomization to 1 year]
• Number of heart failure hospitalizations within 1 year [Срок оценки: From randomization to 1 year]
• Time of the first hospitalization for heart failure within 1 year [Срок оценки: From randomization to 1 year]
• All cause death within 1 year [Срок оценки: From randomization to 1 year]
• Heart failure-related quality of life (KCCQ) [Срок оценки: At baseline, 3-month and 1-year follow-ups.]
• Percentage change of weight [Срок оценки: From randomization to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 26 центров

• Beijing Anzhen Hospital — Пекин
• Guangzhou Red Cross Hospital — Гуанчжоу
• Langfang People's Hospital — Langfang
• Jixi City People's Hospital — Jixi
• Luoyang No.6 People's Hospital — Luoyang
• Ruyang County People's Hospital — Luoyang
• Ningling County People's Hospital — Shangqiu
• Yongcheng People's Hospital — Shangqiu
• … и ещё 18 центров

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34545251

Идентификаторы

NCT: NCT06455878 · Study2024-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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