RECRUITINGPhase 4INTERVENTIONAL
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.
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Age ≥ 18 years.
2. A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
3. Written willing to sign a consent form obtained
Who Should NOT Join This Trial:
1. Previous randomization in the trial
2. Any concomitant condition resulting in a life expectancy of less than one month
3. Previously diagnosed left ventricular ejection fraction \<50%
4. Known cardiomyopathy (except previous Takotsubo syndrome)
5. Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
6. Heart transplant or left ventricular assist device recipient
7. Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
8. Systolic blood pressure \<80 mm Hg at screening
9. Estimated glomerular filtration rate \<30 mL/min/1.73m2
10. Current dialysis
11. Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
12. 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
13. 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)
14. 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 %)
15. Ongoing treatment with dipyridamole
16. Declined participation in study 1
Specific exclusion criteria for Randomization 2
1. Any contra-indication for anticoagulant treatment.
2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy
3. Declined participation in study 2
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Age ≥ 18 years.
2. A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
3. Written informed consent obtained
Exclusion Criteria:
1. Previous randomization in the trial
2. Any concomitant condition resulting in a life expectancy of less than one month
3. Previously diagnosed left ventricular ejection fraction \<50%
4. Known cardiomyopathy (except previous Takotsubo syndrome)
5. Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
6. Heart transplant or left ventricular assist device recipient
7. Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
8. Systolic blood pressure \<80 mm Hg at screening
9. Estimated glomerular filtration rate \<30 mL/min/1.73m2
10. Current dialysis
11. Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
12. 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
13. 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)
14. 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 %)
15. Ongoing treatment with dipyridamole
16. Declined participation in study 1
Specific exclusion criteria for Randomization 2
1. Any contra-indication for anticoagulant treatment.
2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy
3. Declined participation in study 2
Treatments Being Tested
DRUG
Adenosine
Adenosine infusion 70 µg/kg/min for 3 hours.
DRUG
Dipyridamole 200 mg
200 mg b.i.d
DRUG
Apixaban 5 mg Oral Tablet
5mg b.i.d
OTHER
Care 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