Clinical trial NCT06455878: Mobile Applet for Weight Management in Obese Heart Failure Patients
Official title: The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Overweight and Obesity
Weight Loss
Heart Failure With Reduced Ejection Fraction
Lead sponsor: Heart Health Research Center
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Left ventricular ejection fraction (LVEF) ≤40%, NYHA grade II-III;
3. Body mass index (BMI) ≥ 28 kg/m²
4. Ability to use a smart phone and install the dietary management mobile app for adherence assessment through 2 weeks (± 1 week) induction period;
5. History of hospitalization for heart failure within the past 6 months;
6. Signed informed consent.

Exclusion Criteria:

1. 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);
2. Moderate or above anemia (Hb\<90g/L);
3. Renal insufficiency (eGFR\<30 mL/min /1.73 m or undergoing dialysis;
4. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
5. Alcohol or drug abuse;
6. Taking drugs for weight loss or preparing for weight loss surgery;
7. Patients with malignant tumors whose life expectancy is less than 1 year;
8. Situations that researchers believe may hinder compliance with the program, such as habitually ordering takeout or eating in the company cafeteria;
9. Patients with planned hospitalization during the trial;
10. Participating in other interventional clinical studies.

Primary outcomes:
measure: Hierarchical Composite Outcomes
timeFrame: Randomization through 1 year
Secondary outcomes:
measure: Cardiovascular death within 1 year
timeFrame: From randomization to 1 year
measure: Number of heart failure hospitalizations within 1 year
timeFrame: From randomization to 1 year
measure: Time of the first hospitalization for heart failure within 1 year
timeFrame: From randomization to 1 year
measure: All cause death within 1 year
timeFrame: From randomization to 1 year
measure: Heart failure-related quality of life (KCCQ)
timeFrame: At baseline, 3-month and 1-year follow-ups.
measure: Percentage change of weight
timeFrame: From randomization to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Heart Health Research Center
name: Rong Han
role: STUDY_DIRECTOR
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