Mobile Applet for Weight Management in Obese Heart Failure Patients
NCT Number: NCT06455878
Acronym: IDEAL-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Overweight and Obesity|Weight Loss|Heart Failure With Reduced Ejection Fraction
Interventions: BEHAVIORAL: Full usage of diet management app group and with the full usage of an intelligent weight scale|BEHAVIORAL: Limited usage of diet management app group and with the limited usage of an intelligent weight scale
Sponsor: Heart Health Research Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 830
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-06
Completion Date: 2026-12-31

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.

Primary Outcome Measures: 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., Randomization through 1 year
Secondary Outcome Measures: Cardiovascular death within 1 year, Events of Cardiovascular death happened, From randomization to 1 year|Number of heart failure hospitalizations within 1 year, Number of hospitalizations due to heart failure through 1 year, 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, From randomization to 1 year|All cause death within 1 year, Death from any cause through 1 year, 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)., At baseline, 3-month and 1-year follow-ups.|Percentage change of weight, Percentage change of weight compared with baseline, From randomization to 1 year