Beta-Blockers in Takotsubo Syndrome Study

Phase 4

Not yet recruiting

• Conditions: Takotsubo Cardiomyopathy; Beta-blockers; Left Ventricular Function; Echocardiography
• Interventions: Drug: Beta blocker

• Registration Number: NCT06509074
• Lead Sponsor: Spanish Society of Cardiology

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 (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.

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-19
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written informed consent.
• Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography

Exclusion Criteria

• Patients diagnosed of TTS > 48 hours before.
• Persistent ccardiogenic shock or severe hemodynamic instability
• Persistent severe (>30 mmHg) intraventricular gradient
• Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD
• Patients already receiving treatment with betablockers (*)
• Absolute contraindication/indication for beta-blockers (**)
• Poor echocardiographic window
• Pregnant or breastfeeding women.
• Participation in another clinical trial.

(*) Betablockers at a therapeutic dose at the time of symptom´s onset. (**) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta-blockers	Beta blocker	Beta-blockers with alpha or NO activity will be used. Dosage according to responsible physician and current clinical practice

Primary Outcome Measures

Name	Time	Method
Wall motion score index	7 days	Wall motion score index by echocardiography to assess recovery of left ventricular function Wall motion score index (WMSI) ranges from 1 to 4 (1 is normal and 4 worse)

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	7 days	Left ventricular ejection fraction by echocardiography to assess recovery of left ventricular function
Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain	1 month	Changes in LV function by imaging
Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation	1 year	Combined clinical endpoint
Angina and quality of life status during daily life assessed in routine clinical practice	1 year	Evaluated in clinical visits
Global longitudinal strain	7 days	Global longitudinal strain by echocardiography to assess recovery of left ventricular function
Individual endpoints of the combined clinical endpoint Occurrence of death, stroke, recurrent TT, heart failure, acute coronary syndrome, atrial fibrillation will be analyzed and compared individually	1 year	Individual clinical endpoints Occurrence of death, stroke, recurrent TT, heart failure, acute coronary syndrome, atrial fibrillation will be analyzed and compared individually in the 2 groups

Trial Locations

Locations (1)

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain