Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509074
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Beta-Blockers in Takotsubo Syndrome Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Beta-Blockers in Takotsubo Syndrome Study A Randomized Clinical Trial β-Tako
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
β-Tako
Brief Summary:
The Beta-blockers in Takotsubo syndrome TTS β-Tako trial is an academic pragmatic prospective multicenter randomized clinical trial aiming to assess the efficacy of beta-blockers BB in TTS patients Two-hundred patients with TTS will be randomized 11 to BB n100 or no BB n100 BB with alpha or nitric oxide release activity will be used in the treatment arm The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days A composite clinical endpoint death stroke admission for recurrent TTS ACS heart failure or atrial fibrillation at 1 year will be assessed by an independent clinical events committee Several sub-studies will be performed The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity
Detailed Description:
Takotsubo syndrome TTS is a cardiac condition mimicking acute coronary syndrome ACS characterized by transient left ventricular LV dysfunction in the presence of normal coronary arteries Its etiology remains unknown but reversible microvascular dysfunction secondary to an adrenergic surge appears implicated Treatment is empiric although in clinical practice most patients receive beta-blockers BB The Beta-blockers in TTS β-Tako trial is an academic pragmatic prospective multicenter randomized clinical trial aiming to assess the efficacy of BB in TTS patients TTS diagnosis will be confirmed by invasive coronary angiography and serial echocardiographic studies Two-hundred patients with TTS will be randomized 11 to BB n100 or no BB n100 BB with alpha or nitric oxide release activity will be used in the treatment arm The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days analyzed in an independent corelab Changes in LV ejection fraction and global longitudinal strain will be also evaluated A composite clinical endpoint death stroke admission for recurrent TTS ACS heart failure or atrial fibrillation at 1 year will be assessed by an independent clinical events committee Several sub-studies clinical imaging biomarkers pharmacogenetic mRNAs quality of life will be performed The β-Tako trial will generate valuable scientific evidence to address unmet clinical needs and inform clinical and treatment decisions in this uniquely challenging clinical entity
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