Mobile Applet for Weight Management in Obese Heart Failure Patients
- Conditions
- Overweight and ObesityWeight LossHeart FailureHeart Failure With Reduced Ejection Fraction
- Interventions
- Behavioral: Full usage of diet management app group and with the full usage of an intelligent weight scaleBehavioral: Limited usage of diet management app group and with the limited usage of an intelligent weight scale
- Registration Number
- NCT06455878
- Lead Sponsor
- Heart Health Research Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 830
- Age ≥18 years old;
- Left ventricular ejection fraction (LVEF) ≤40%, NYHA grade II-III;
- Body mass index (BMI) ≥ 28 kg/m²
- Ability to use a smart phone and install the dietary management mobile app for adherence assessment through 2 weeks (± 1 week) induction period;
- History of hospitalization for heart failure within the past 6 months;
- Signed informed consent.
- End-stage heart failure (2 or more hospitalizations for heart failure in the past 3 months, or inability to tolerate guide-recommended drug therapy (GDMT), or positive inotropic drug dependence);
- Moderate or above anemia (Hb<90g/L);
- Renal insufficiency (eGFR<30 mL/min /1.73 m or undergoing dialysis;
- Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
- Alcohol or drug abuse;
- Taking drugs for weight loss or preparing for weight loss surgery;
- Patients with malignant tumors whose life expectancy is less than 1 year;
- Situations that researchers believe may hinder compliance with the program, such as habitually ordering takeout or eating in the company cafeteria;
- Patients with planned hospitalization during the trial;
- Participating in other interventional clinical studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full usage of diet management app group and with the full usage of an intelligent weight scale 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). Limited usage of diet management app group and with the limited usage of an intelligent weight scale 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).
- Primary Outcome Measures
Name Time Method Hierarchical Composite Outcomes 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 Outcome Measures
Name Time Method Heart failure-related quality of life (KCCQ) 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).
All cause death within 1 year From randomization to 1 year Death from any cause through 1 year
Percentage change of weight From randomization to 1 year Percentage change of weight compared with baseline
Time of the first hospitalization for heart failure within 1 year From randomization to 1 year The time of the first hospitalization in days for heart failure within 1 year
Cardiovascular death within 1 year From randomization to 1 year Events of Cardiovascular death happened
Number of heart failure hospitalizations within 1 year From randomization to 1 year Number of hospitalizations due to heart failure through 1 year