Beta-Blockers in Takotsubo Syndrome Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpanish Society of Cardiology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent.
Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Beta blocker
DrugPragmatic design. Any beta-blocker with alpha or NO activity may be used
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Beta-blockersExperimental treatment 1 intervention
Group B: No beta-blockersNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Wall motion score index
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)
Time frame
7 daysSecondary outcomes
1
Left ventricular ejection fraction
Left ventricular ejection fraction by echocardiography to assess recovery of left ventricular function
Time frame
7 days2
Global longitudinal strain
Global longitudinal strain by echocardiography to assess recovery of left ventricular function
Time frame
7 days3
Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain
Changes in LV function by imaging
Time frame
7 days4
Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain
Changes in LV function by imaging
Time frame
1 monthOther outcomes
1
Cardiac Magnetic Resonance (CMR)
CMR to detect edema, late gadolinium enhancement to correlate with clinical data and prognosis
Time frame
1 year2
ECG
Correlation of ECG findings with clinical features and prognosis Different ECG parameters will be correlated with the echocardiographic and clinical outcome measures to detect potential correlations
Time frame
1 year3
Pharmacogenetic substudy
To assess pharmacogenetic implications of different beta-blockers used The pharcacogenetics of the 2 different betablockers used in this study will be studied in relation to the main echocardiographic and clinical endpoints
Time frame
1 year4
Coronary angiography
To assess correlation with angiographic features and clinical findings and prognosis
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Spanish Society of Cardiology
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborator
Source ClinicalTrials.gov
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