Beta-Blockers in Takotsubo Syndrome Study

NCT06509074 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Takotsubo Cardiomyopathy; beta-blockers; echocardiography; left ventricular function; acute myocardial infarction; acute coronary syndrome; coronary angiography; Normal coronary arteries; Heart failure; stress

Outcome Measures

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)

  7 days

Secondary Outcomes (7)

• Left ventricular ejection fraction

  7 days

• Global longitudinal strain

  7 days

• Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain

  7 days

• Delta (Change) in: wall motion score index, left ventricular ejection fraction, global longitudinal strain

  1 month

• Combined clinical endpoint (death, stroke, recurrent TTS, heart failure, acute coronary syndrome, atrial fibrillation

  1 year

Other Outcomes (5)

• Cardiac Magnetic Resonance (CMR)

  1 year

• ECG

  1 year

• Pharmacogenetic substudy

  1 year

Study Arms (2)

Beta-blockers

EXPERIMENTAL

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

Drug: Beta blocker

No beta-blockers

NO INTERVENTION

No beta-blockers

Interventions

Beta blocker DRUG

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

Also known as: Other medications according to local clinical practice protocols and current guidelines

Beta-blockers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Cardiology: lead
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Related Publications (1)

• 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.

  PMID: 39743172 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Acute Coronary Syndrome; Heart Failure

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Fernando Alfonso, MD

  Hospital Universitario La Princesa, Madrid. IIS-IP

  STUDY CHAIR

Central Study Contacts

Fernando Alfonso, MD

CONTACT

34 680483165; falf@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors blinded to treatment allocation Blinded independent clinical event committee PROBE initiative
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Cardiac Department

Model Details: Randomized trial with 2 arms

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year after publication of the main combined clinical endpoint
• Access Criteria: to be defined

Locations

ES (1)