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

Vastra Gotaland Region

Status and phase: Enrolling; Phase 4

Conditions: Takotsubo Syndrome

Treatments: Drug: Dipyridamole 200 mg; Other: Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome; Drug: Adenosine; Drug: Apixaban 5 mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04666454

BROKEN SWEDEHEART

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

Randomisation 1: Adenosine and Dipyridamole

Active Comparator group

Description:

Adenosine 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.

Treatment:

Drug: Adenosine

Drug: Dipyridamole 200 mg

Randomisation 1: Control

Other group

Description:

Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.

Treatment:

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: Apixaban

Active Comparator group

Description:

Apixaban 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.

Treatment:

Drug: Apixaban 5 mg Oral Tablet

Randomisation 2: No anticoagulant therapy

No Intervention group