Status:
NOT_YET_RECRUITING
Beta-Blockers in Takotsubo Syndrome Study
Lead Sponsor:
Spanish Society of Cardiology
Collaborating Sponsors:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions:
Takotsubo Cardiomyopathy
Beta-blockers
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 e...
Eligibility Criteria
Inclusion
- Written informed consent.
- Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06509074
Start Date
August 1 2024
End Date
December 1 2026
Last Update
August 26 2024
Active Locations (1)
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1
Hospital Universitario de la Princesa
Madrid, Spain, 28006