Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-01
Brief Title:
The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
The Efficacy of Enavogliflozin on Exercise Performance and Diastolic Function in Heart Failure With Preserved Ejection Fraction A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
ENRICH-PEF
Brief Summary:
The aim of prospective open label single center randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance diastolic dysfunction and quality of life in patients with heart failure with preserved ejection fraction HFpEF
Detailed Description:
HFpEF is a clinically heterogenous syndrome and has unique characteristics that differ from the other entities of heart failure Cardiovascular and non-cardiovascular comorbidities are known to contribute to the pathogenesis of HFpEF and consequently the importance of HFpEF is increasingly emphasized as the population ages In fact HFpEF occurs in approximately 5 of the general population aged over 60 years and account for half of hospitalization for heart failure Notwithstanding no medication has been found to be effective for HFpEF Only recently Sodium glucose cotransporter 2 SGLT2 inhibitors was proven effective in patients with HFpEF in two landmark trials EMPEROR-Preserved and DELIVER trials In both trials SGLT2 inhibitor was consistently associated with reduced risk of composite outcome of cardiovascular death and hospitalization for heart failure In this regard 2023 focused update of the 2021 European Society of Cardiology ESC guidelines for heart failure recommends SGLT2 inhibitor as class 1A recommendation in patients with HFpEF
Despite the solid evidence about the clinical benefit of SGLT2 inhibitor in patients with HFpEF little is known about the mechanisms responsible for the beneficial cardiac effects of SGLT2 inhibitor Patients with HFpEF are known to have impaired exercise and functional capacity which lead to declined quality of life and debilitating symptoms Along with unclear mechanisms responsible for the beneficial cardiac effect of SGLT2 inhibitor the impacts of SGLT2 inhibitor on exercise and functional capacity in patients with HFpEF have also not been clearly evaluated Therefore this trial aim to evaluate the impact of SGLT2 inhibitor on exercise performance diastolic function and quality of life in patients with HFpEF using newly developed SGLT2 inhibitor Enavogliflozin
Despite the solid evidence about the clinical benefit of SGLT2 inhibitor in patients with HFpEF little is known about the mechanisms responsible for the beneficial cardiac effects of SGLT2 inhibitor Patients with HFpEF are known to have impaired exercise and functional capacity which lead to declined quality of life and debilitating symptoms Along with unclear mechanisms responsible for the beneficial cardiac effect of SGLT2 inhibitor the impacts of SGLT2 inhibitor on exercise and functional capacity in patients with HFpEF have also not been clearly evaluated Therefore this trial aim to evaluate the impact of SGLT2 inhibitor on exercise performance diastolic function and quality of life in patients with HFpEF using newly developed SGLT2 inhibitor Enavogliflozin
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