Beta-Blockers in Takotsubo Syndrome Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beta blocker.
- Who it may be relevant to
- Registry conditions: Takotsubo Cardiomyopathy, Beta-blockers, Echocardiography, Left Ventricular Function. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)
Overview
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.
Interventions
- Drug Beta blocker
Pragmatic design. Any beta-blocker with alpha or NO activity may be used
Primary outcome measures
- Wall motion score index [Time frame: 7 days]
Secondary outcome measures (7)
- Left ventricular ejection fraction [Time frame: 7 days]
- Global longitudinal strain [Time frame: 7 days]
- Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain [Time frame: 7 days]
- Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain [Time frame: 1 month]
- Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation [Time frame: 1 year]
- 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 [Time frame: 1 year]
- Angina and quality of life status during daily life assessed in routine clinical practice [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Universitario de la Princesa — Madrid
Publications
- Alfonso F, Salamanca J, Nunez-Gil I, Ibanez B, Sanchis J, Sabate M, Velazquez M, Raposeiras-Roubin S, Garcia-Camarero T, Antuna P, Mejia H, Carrillo X, Buera I, Martinez-Selles M, Escudier-Villa JM, Sanchez-Prieto J, Blanco Ponce E, Cabezon G, Fernandez-Golfin C, Pascual-Figal D, Cid B, Marcano A, Gonzalez-Manzanares R, Jimenez-Valero S, Vazquez JM, Sanz-Sanchez J, Cecconi A, Del Val D, Abad-Santo PMID 39743172
Identifiers
NCT: NCT06509074 · 10