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Takotsubo SyndromePhase 4NCT04666454

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

A Phase 4 study testing Adenosine, Dipyridamole 200 mg and Apixaban 5 mg Oral Tablet in people with Takotsubo Syndrome, run by Vastra Gotaland Region at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Takotsubo Syndrome
What is being tested?
Adenosine, Dipyridamole 200 mg and Apixaban 5 mg Oral Tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
16 sitesin 3 countries
Study dates
14 Dec 2020to Dec 2028
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

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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Elmir Omerovic, MD PhD contact

31 3421000 ext. +46

elmir@wlab.gu.se

Björn Redfors, MD, PhD contact

31 3421000 ext. +46

16 sites in 3 countries

Sweden13 sites, 13 recruiting

  • Region Dalarna

    Falun

    Per Lundberg, MD

    Recruiting

  • Sahlgrenska University Hospital, Department of Cardiology

    Gothenburg

    Recruiting

  • Skaraborg Hospital

    Gothenburg

    Lisa Brandin, MD

    Recruiting

  • Region Skane Helsingborg Hospital

    Helsingborg

    Sven-Erik Olsson, MD

    Recruiting

  • Region Jönköpings Län

    Jönköping, Region Jönköping, 55111

    Dario Gulin, MD, 010-241 00 00, dario.gulin@rjl.se

    Dario Gulin, MD

    Recruiting

  • Region Oestergoetland

    Linköping

    Joakim Alfredsson, MD

    Recruiting

  • Region Skane - Skanes Universitetssjukhus

    Lund

    Nazim Isma, MD

    Recruiting

  • Region Orebro lan

    Örebro

    Anna Nordenskjöld, MD

    Recruiting

  • Östersund Sjukhus

    Östersund, Jämtland Härjedalen, 831 27

    Fredrik Björklund, MD, 063-14 75 00, fredrik.bjorklund@regionjh.se

    Fredrik Björklund, MD

    Recruiting

  • Danderyds Hospital, Department of Cardiology

    Stockholm

    Christina Ekenbäck, MD

    Recruiting

  • Karolinska University Hospital, Huddinge, Department of Cardiology

    Stockholm

    Loghman Henareh, MD

    Recruiting

  • Norra Älvsborgs länssjukhus

    Trollhättan, Västra Götalands Region, 46173

    Imran Tahir, MD, 010-435 00 00, imran.tahir@vgregion.se

    Imran Tahir, MD

    Recruiting

  • Umeå University Hospital, Department of Cardiology

    Umeå

    Henrik Hagström, MD

    Recruiting

Other trials in Sweden

Denmark2 sites, 2 recruiting

  • Aarhus Universitetshospital

    Aarhus

    Steen Hvitfeldt Poulsen, MD

    Recruiting

  • Rigshospitalet

    Copenhagen

    Lia Evi Bang, MD

    Recruiting

Other trials in Denmark

Norway1 site, 1 recruiting

  • Oslo University Hospital

    Oslo

    Njord Nordstrand, MD

    Recruiting

Other trials in Norway

About this study

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

Being tested
Adenosine, Dipyridamole 200 mg, Apixaban 5 mg Oral Tablet, Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome
Medical subject headings
Takotsubo Cardiomyopathy

What participants receive

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

  • AdenosineDrug

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

  • Dipyridamole 200 mgDrug

    200 mg b.i.d

  • Apixaban 5 mg Oral TabletDrug

    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 syndromeOther

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

Study groups in NCT04666454
Study groupRoleWhat they receive
Randomisation 1: Adenosine and DipyridamoleActive comparatorAdenosine infusion 70 µg/kg/min for 3 hours, followed (first dose 60 minutes apart from the end of the adenosine infusion) by daily oral treatment with the adenosine reuptake inhibitor dipyridamole (200 mg b.i.d.) until normalization of Left Ventricular (LV) function (EF≥50%) is documented on the study-specific echocardiographic assessment at 48-96 hours or at any subsequent echocardiographic examination, or for 30+7 Days.
Receives: Drug: Adenosine; Drug: Dipyridamole 200 mg
Randomisation 1: ControlOtherCare as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.
Receives: Other: Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome
Randomisation 2: ApixabanActive comparatorApixaban 5mg b.i.d. per oral until normalization of LV function (EF≥50%) is documented on the study-specific echocardiographic assessment at 48-96 hours or any subsequent echocardiographic examination, or for 30+7 Days.
Receives: Drug: Apixaban 5 mg Oral Tablet
Randomisation 2: No anticoagulant therapyNo interventionNot described

What is being measured

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

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

    Measured: 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%

    Measured: 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

    Measured: up until day 30 respectively 48-96 hours

Secondary outcomes (13)

  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%

    Measured: all time to the first occurrence up until day 30 respectively at 48-96 hours (binary)

  2. Randomization 1: Ejection fraction

    Measured: at 48-96 hours (continuous)

  3. Randomization 1: Any sustained ventricular tachycardia or fibrillation

    Measured: within 48-96 hours (binary)

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

    Measured: within 48-96 hours (binary)

  5. Randomization 1: Need for cardiac assist device

    Measured: up until day 30 day (binary)

  6. Randomization 1: Death

    Measured: up until day 30 (binary)

  7. Randomization 1: Stroke

    Measured: 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)

    Measured: up until day 30

  9. Randomization 2: Presence of cardiac thrombus

    Measured: at 48-96 hours

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

    Measured: up until day 30 (binary)

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

    Measured: up until day 30 (binary)

  12. Randomization 2: BARC grade 3-5

    Measured: up until day 30 (binary)

  13. Randomization 2: Any blood transfusion

    Measured: up until day 30 (binary)

Timeline

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

  1. First posted14 Dec 2020
  2. Study start14 Dec 2020
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (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
Factorial
Model description
Multinational, Multicentre, registry-based, open-label, randomized controlled trial with 2 × 2 factorial design
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666454
Sponsor's protocol ID
BROKEN SWEDEHEART
Status last verified
Nov 2024
First submitted
7 Dec 2020
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: To be decided.

Publications

  • Omerovic E, James S, Erlinge D, Hagstrom H, Venetsanos D, Henareh L, Ekenback C, Alfredsson J, Hambreus K, Redfors B. Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome. Am Heart J. 2023 Mar;257:33-40. doi: 10.1016/j.ahj.2022.11.010. Epub 2022 Nov 23.

    PubMed 36435233

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adenosine, Dipyridamole 200 mg and Apixaban 5 mg Oral Tablet in people with Takotsubo Syndrome, run by Vastra Gotaland Region at 16 sites in 3 countries.

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 3 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Sweden, Denmark, Norway. 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 Elmir Omerovic, MD PhD (31 3421000 ext. +46, elmir@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. 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 NCT04666454, 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 2 Dec 2024.

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