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BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.

ConditionTakotsubo Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline

Written informed consent obtained

Disqualifiers

Previous randomization in the trial

Any concomitant condition resulting in a life expectancy of less than one month

Previously diagnosed left ventricular ejection fraction <50%

Known cardiomyopathy (except previous Takotsubo syndrome)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Adenosine

    Drug

    Adenosine infusion 70 µg/kg/min for 3 hours.

  • Dipyridamole 200 mg

    Drug

    200 mg b.i.d

  • Apixaban 5 mg Oral Tablet

    Drug

    5mg b.i.d

  • Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome

    Other intervention

    This treatment will vary depending on local routines and the degree of adherence to the recommendations.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Randomisation 1: Adenosine and DipyridamoleActive comparator 2 interventions
Group B: Randomisation 1: ControlOther 1 intervention
Group C: Randomisation 2: ApixabanActive comparator 1 intervention
Group D: Randomisation 2: No anticoagulant therapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography)

Time frame
48-96 hours
2

Randomization 1: Second co-primary endpoint: The occurrence of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device, or re-hospitalization for heart failure or ejection fraction <50%

Time frame
up until day 30 day respectively at 48-96 hours
3

Randomization 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death, or the presence of a cardiac thrombus, as assessed by echocardiography

Time frame
up until day 30 respectively 48-96 hours

Secondary outcomes

1

Randomization 1: The hierarchical occurrence (in descending order of importance) of time to death, time to cardiac assist device, time to cardiac arrest and ejection fraction <50%

Time frame
all time to the first occurrence up until day 30 respectively at 48-96 hours (binary)
2

Randomization 1: Ejection fraction

Time frame
at 48-96 hours (continuous)
3

Randomization 1: Any sustained ventricular tachycardia or fibrillation

Time frame
within 48-96 hours (binary)
4

Randomization 1: Any high-grade atrioventricular block or sinus arrest

Time frame
within 48-96 hours (binary)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Göteborg University

Collaborator

Source ClinicalTrials.gov
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