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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
830
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.
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.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou Red Cross Hospital
Guangzhou, Guangdong, China
RECRUITINGLangfang People's Hospital
Langfang, Hebei, China
RECRUITINGJixi City People's Hospital
Jixi, Heilongjiang, China
RECRUITINGLuoyang No.6 People's Hospital
Luoyang, Henan, China
RECRUITINGRuyang County People's Hospital
Luoyang, Henan, China
RECRUITINGNingling County People's Hospital
Shangqiu, Henan, China
RECRUITINGYongcheng People's Hospital
Shangqiu, Henan, China
RECRUITINGShangcheng County People's Hospital
Xinyang, Henan, China
RECRUITINGHenan Provincial Chest Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITING...and 16 more locations
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.
Time frame: Randomization through 1 year
Cardiovascular death within 1 year
Events of Cardiovascular death happened
Time frame: From randomization to 1 year
Number of heart failure hospitalizations within 1 year
Number of hospitalizations due to heart failure through 1 year
Time frame: From randomization to 1 year
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
Time frame: From randomization to 1 year
All cause death within 1 year
Death from any cause through 1 year
Time frame: From randomization to 1 year
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).
Time frame: At baseline, 3-month and 1-year follow-ups.
Percentage change of weight
Percentage change of weight compared with baseline
Time frame: From randomization to 1 year
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