Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580717
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-25
Brief Title:
ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy a Prospective Multicenter Randomized Double-blind Placebo-controlled Study ENDEAVOR-HCM
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to investigate the effect of enavogliflozin an Sodium-glucose transporter 2 SGLT2 inhibitor compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy The secondary objective of this study is to investigate the effect of enavogliflozin on exercise capacity symptoms serum biomarkers and arrhythmic burden in patients with nonobstructive hypertrophic cardiomyopathy
Detailed Description:
Most of the medication used in HCMhypertrophic cardiomyopathy targets dynamic left ventricular obstruction and hypercontractility Guidelines recommend that beta-blockers and calcum channels can also be used to lower heart rate and improve diastolic function in symptomatic nonobstructive HCMhypertrophic cardiomyopathy and that diuretics may be considered next but there is a paucity of evidence supporting these recommendations Left ventricular diastolic dysfunction is the main pathophysiological mechanism in nonobstructive HCM SGLT2Sodium-glucose transporter 2 inhibitors have been shown to reduce heart failure events and mortality in patients with heart failure with preserved ejection fraction and have also been reported to improve left ventricular diastolic function This study will investigate the efficacy and safety of enavogliflozin an SGLT2Sodium-glucose transporter 2 inhibitor compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy over a period of 6 months
Patients with hypertrophic cardiomyopathy and without evidence of dynamic left ventricular outflow tract obstruction at resting or on provocation by Valsalva maneuver or exercise will be enrolled Participants will be randomly assigned to the enavogliflozin 03mg group and the placebo group in a 11 ratio and will continue the medication for 24 weeks Changes in left ventricular diastolic reserve assessed by diastolic stress echocardiography will be compared between the treatment groups at 24 weeks Changes in other parameters of diastolic function and exercise capacity will be assessed by diastolic stress echocardiography and compared between the treatment groups Symptom status serum biomarker levels and arrhythmic burden on 24 hour ambulatory electrocardiogram will also be compared between the treatment groups Post-trial follow-up will be performed at 52 weeks
Patients with hypertrophic cardiomyopathy and without evidence of dynamic left ventricular outflow tract obstruction at resting or on provocation by Valsalva maneuver or exercise will be enrolled Participants will be randomly assigned to the enavogliflozin 03mg group and the placebo group in a 11 ratio and will continue the medication for 24 weeks Changes in left ventricular diastolic reserve assessed by diastolic stress echocardiography will be compared between the treatment groups at 24 weeks Changes in other parameters of diastolic function and exercise capacity will be assessed by diastolic stress echocardiography and compared between the treatment groups Symptom status serum biomarker levels and arrhythmic burden on 24 hour ambulatory electrocardiogram will also be compared between the treatment groups Post-trial follow-up will be performed at 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None