Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05897489
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-05-26
Brief Title:
SGLT2 for Heart Failure in CHD Patients
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-05
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:
GACH
Brief Summary:
Heart failure HF in adult patients with congenital heart disease is a major cause of morbidity and mortality Approximately 30 of patients with significant congenital heart disease will develop signs of heart failure Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease One-third of deaths in patients with congenital heart disease are attributable to heart failure
In patients with heart failure and reduced ejection fraction EF 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors SGLT2i dapaglifozin and empaglifozin a new therapeutic class for heart failure HF in a class IA recommendation In addition to reduced EF these molecules have shown efficacy in preserved EF leading to their reimbursement in both preserved and reduced ejection fraction in France
Unfortunately given the relatively low number of HF-congenital heart disease patients they were not included in previous studies However the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future This especially underlines the need for safety data in this real-world population
To date no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease
The objective of this study is to assess on real-life data through a multicenter registry
The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use type of congenital heart disease
The safety of SGLT2i collection of adverse events
In patients with heart failure and reduced ejection fraction EF 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors SGLT2i dapaglifozin and empaglifozin a new therapeutic class for heart failure HF in a class IA recommendation In addition to reduced EF these molecules have shown efficacy in preserved EF leading to their reimbursement in both preserved and reduced ejection fraction in France
Unfortunately given the relatively low number of HF-congenital heart disease patients they were not included in previous studies However the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future This especially underlines the need for safety data in this real-world population
To date no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease
The objective of this study is to assess on real-life data through a multicenter registry
The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use type of congenital heart disease
The safety of SGLT2i collection of adverse events
Detailed Description:
None
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