Beta-Blockers in Takotsubo Syndrome Study

NCT ID: NCT06509074

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Beta-blockers

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

Group Type: EXPERIMENTAL

Beta blocker

Intervention Type: DRUG

Pragmatic design. Any beta-blocker with alpha or NO activity may be used

No beta-blockers

No beta-blockers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Beta blocker

Pragmatic design. Any beta-blocker with alpha or NO activity may be used

Intervention Type: DRUG

Other Intervention Names

Other medications according to local clinical practice protocols and current guidelines

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: collaborator

Spanish Society of Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Fernando Alfonso

Head Cardiac Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Alfonso, MD

Role: STUDY_CHAIR

Hospital Universitario La Princesa, Madrid. IIS-IP

Locations

Hospital Universitario de la Princesa

Madrid, , Spain

Countries

Spain

Central Contacts

Fernando Alfonso, MD

Role: CONTACT

falf@hotmail.com

34 680483165

Facility Contacts

Fernando Alfonso, MD

Role: primary

falf@hotmail.com

34 680483165

References

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-Santos F, Crea F. Rationale and design of the beta-blockers in tako-tsubo syndrome study: a randomized clinical trial (beta-Tako). Rev Esp Cardiol (Engl Ed). 2025 Jul;78(7):592-599. doi: 10.1016/j.rec.2024.12.006. Epub 2024 Dec 30. English, Spanish.

Reference Type: DERIVED

PMID: 39743172 (View on PubMed)

Other Identifiers

10

Identifier Type: -

Identifier Source: org_study_id