Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455878
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-03
Brief Title:
Mobile Applet for Weight Management in Obese Heart Failure Patients
Sponsor:
Heart Health Research Center
Organization:
Heart Health Research Center
Study Overview
Official Title:
The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients a Multicenter Single-blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL-HF
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None