RecruitingPhase 4NCT04666454

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

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


Sponsor

Vastra Gotaland Region

Enrollment

1,000 participants

Start Date

Dec 14, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria19

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

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Interventions

DRUGAdenosine

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

DRUGDipyridamole 200 mg

200 mg b.i.d

DRUGApixaban 5 mg Oral Tablet

5mg b.i.d

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

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


Locations(16)

Aarhus Universitetshospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Oslo University Hospital

Oslo, Norway

Östersund Sjukhus

Östersund, Jämtland Härjedalen, Sweden

Region Jönköpings Län

Jönköping, Region Jönköping, Sweden

Norra Älvsborgs länssjukhus

Trollhättan, Västra Götalands Region, Sweden

Region Dalarna

Falun, Sweden

Sahlgrenska University Hospital, Department of Cardiology

Gothenburg, Sweden

Skaraborg Hospital

Gothenburg, Sweden

Region Skane Helsingborg Hospital

Helsingborg, Sweden

Region Oestergoetland

Linköping, Sweden

Region Skane - Skanes Universitetssjukhus

Lund, Sweden

Region Orebro lan

Örebro, Sweden

Danderyds Hospital, Department of Cardiology

Stockholm, Sweden

Karolinska University Hospital, Huddinge, Department of Cardiology

Stockholm, Sweden

Umeå University Hospital, Department of Cardiology

Umeå, Sweden

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NCT04666454


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