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Takotsubo CardiomyopathyPhase 4β-TakoNCT06509074

Beta-Blockers in Takotsubo Syndrome Study

A Phase 4 study testing Beta blocker in people with Takotsubo Cardiomyopathy and Beta-blockers, run by Spanish Society of Cardiology at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Beta blocker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
Aug 2024to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography

Who cannot join

  • 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 (**)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fernando Alfonso, MD contact

34 680483165

falf@hotmail.com

Spain1 site

  • Hospital Universitario de la Princesa

    Madrid, 28006

    Fernando Alfonso, MD, 34 680483165, falf@hotmail.com

    Fernando Alfonso, MD

Other trials in Spain

About this study

Official title: Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)

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.

Read the 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.

Being tested
Beta blocker
Keywords
Takotsubo Cardiomyopathy, beta-blockers, echocardiography, left ventricular function, acute myocardial infarction, acute coronary syndrome, coronary angiography, Normal coronary arteries, Heart failure, stress
Medical subject headings
Takotsubo Cardiomyopathy, Acute Coronary Syndrome, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beta blockerDrug

    Also called Other medications according to local clinical practice protocols and current guidelines

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

Study groups in NCT06509074
Study groupRoleWhat they receive
Beta-blockersExperimentalBeta-blockers with alpha or NO activity will be used. Dosage according to responsible physician and current clinical practice
Receives: Drug: Beta blocker
No beta-blockersNo interventionNo beta-blockers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 7 days

Secondary outcomes (7)

  1. Left ventricular ejection fraction

    Left ventricular ejection fraction by echocardiography to assess recovery of left ventricular function

    Measured: 7 days

  2. Global longitudinal strain

    Global longitudinal strain by echocardiography to assess recovery of left ventricular function

    Measured: 7 days

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

    Changes in LV function by imaging

    Measured: 7 days

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

    Changes in LV function by imaging

    Measured: 1 month

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

    Combined clinical endpoint

    Measured: 1 year

  6. 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

    Individual clinical endpoints Occurrence of death, stroke, recurrent TT, heart failure, acute coronary syndrome, atrial fibrillation will be analyzed and compared individually in the 2 groups

    Measured: 1 year

  7. Angina and quality of life status during daily life assessed in routine clinical practice

    Evaluated in clinical visits

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized trial with 2 arms
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509074
Sponsor's protocol ID
10
Acronym
β-Tako
Status last verified
Aug 2024
First submitted
8 Jul 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be considered to be shared by the PI and steering committee, upon adequate and justified request, within a defined scientific research project, and providing adequate supervision of the analysis and credit to the original inverstigators is prearranged

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-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.

    PubMed 39743172

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beta blocker in people with Takotsubo Cardiomyopathy and Beta-blockers, run by Spanish Society of Cardiology at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernando Alfonso, MD (34 680483165, falf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wall motion score index (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06509074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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