NCT06509074

Beta-Blockers in Takotsubo Syndrome Study

Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (1:1) to BB (n=100) or no BB (n=100). 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 (1:1) to BB (n=100) or no BB (n=100). 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.

Conditions

• Takotsubo Cardiomyopathy
• Beta-blockers
• Echocardiography
• Left Ventricular Function

Interventions

Type	Name	Description
DRUG	Beta blocker	Pragmatic design. Any beta-blocker with alpha or NO activity may be used

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-07-19
• Last updated: 2024-08-26

Locations

1 site across 1 country: Spain