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NCT Number: NCT04666454

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

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.

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Key information

Conditions

Takotsubo Syndrome Cardiomyopathies Cardiovascular Diseases Heart Diseases Takotsubo Cardiomyopathy Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus Universitetshospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
  • Written informed consent obtained

Exclusion criteria

  • 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)
  • Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
  • Heart transplant or left ventricular assist device recipient
  • Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
  • Systolic blood pressure <80 mm Hg at screening
  • Estimated glomerular filtration rate <30 mL/min/1.73m2
  • Current dialysis
  • Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
  • Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to the trial protocol

Specific exclusion criteria for Randomization 1

  • Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick-sinus syndrome in subjects who don´t have a functioning pacemaker, unstable angina, ongoing treatment with dipyridamole)
  • Severe asthma (defined as asthma requiring medium or high-dose inhaled corticosteroids combined with other long-acting medications) and severe Chronic Obstructive Pulmonary Disease (COPD), (defined as FEV-1 ˂ 50 %)
  • Ongoing treatment with dipyridamole
  • Declined participation in study 1

Specific exclusion criteria for Randomization 2

  • Any contra-indication for anticoagulant treatment.
  • Current indication for treatment with, anticoagulant or dual antiplatelet therapy
  • Declined participation in study 2

Treatment and study plan

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

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

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)

  5. Randomization 1: Need for cardiac assist device

    Time frame: up until day 30 day (binary)

  6. Randomization 1: Death

    Time frame: up until day 30 (binary)

  7. Randomization 1: Stroke

    Time frame: up until day 30 (binary)

  8. Randomization 1: Worsening heart failure in hospital (defined as worsening signs or symptoms of heart failure, necessitating intensification of intravenous pharmacologic heart failure therapy or mechanical ventilation)

    Time frame: up until day 30

  9. Randomization 2: Presence of cardiac thrombus

    Time frame: at 48-96 hours

  10. Randomization 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major

    Time frame: up until day 30 (binary)

  11. Randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5

    Time frame: up until day 30 (binary)

  12. Randomization 2: BARC grade 3-5

    Time frame: up until day 30 (binary)

  13. Randomization 2: Any blood transfusion

    Time frame: up until day 30 (binary)

Study contacts

Contact information is provided by the study sponsor or research team.

Björn Redfors, MD, PhD

CONTACT

31 3421000 ext. +46

Elmir Omerovic, MD PhD

CONTACT

[email protected]

31 3421000 ext. +46

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Dec 14, 2020
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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