Mobile Applet for Weight Management in Obese Heart Failure Patients

Heart Failure Clinical Trial

— IDEAL-HF  

Official title:

The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455878
• Other study ID #: Study2024-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Heart Health Research Center
• Contact: Yangyang Zhao
• Phone: +8618513340674
• Email: zhao.yangyang[@]hhresearch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 830
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Full 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.
• Limited 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heart Health Research Center

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death within 1 year	Events of Cardiovascular death happened	From randomization to 1 year
Secondary	Number of heart failure hospitalizations within 1 year	Number of hospitalizations due to heart failure through 1 year	From randomization to 1 year
Secondary	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
Secondary	All cause death within 1 year	Death from any cause through 1 year	From randomization to 1 year
Secondary	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.
Secondary	Percentage change of weight	Percentage change of weight compared with baseline	From randomization to 1 year