Heart Failure, Heart Failure With Reduced Ejection Fraction, Overweight and Obesity, Weight Loss
Conditions
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.
Interventions
BEHAVIORALFull 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.
BEHAVIORALLimited 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.
Sponsors
Heart Health Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years; 2. Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III; 3. 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; 4. Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period; 5. History of heart failure hospitalization within the past 6 months; 6. Signed informed consent.
Exclusion criteria
1. 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); 2. Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis); 3. Moderate or severe anemia (hemoglobin \[Hb\] \<90 g/L); 4. Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²) or ongoing dialysis; 5. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure; 6. Alcohol or substance abuse; 7. Current use of weight-loss medications or planned bariatric surgery; 8. Malignancy with an expected survival \<1 year; 9. Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals); 10. Planned hospitalization during the trial period; 11. Concurrent participation in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of heart failure hospitalizations within 1 year | From randomization to 1 year | Number of hospitalizations due to heart failure through 1 year |
| 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 |
| 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). |
| Percentage change of weight | From randomization to 1 year | Percentage change of weight compared with baseline |
| All cause death within 1 year | From randomization to 1 year | Death from any cause through 1 year |
Countries
China
Contacts
Primary ContactYangyang Zhao
Outcome results
None listed