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

Takotsubo Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666454
• Other study ID #: BROKEN SWEDEHEART
• Status: Recruiting
• Phase: Phase 4
• Start date: December 14, 2020
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: Vastra Gotaland Region
• Contact: Elmir Omerovic, MD PhD
• Phone: 31 3421000
• Email: elmir[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Takotsubo Cardiomyopathy
• Takotsubo Syndrome

Intervention

Drug:
• Adenosine
Adenosine infusion 70 µg/kg/min for 3 hours.
• Dipyridamole 200 mg
200 mg b.i.d
• 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

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Norway	Oslo University Hospital	Oslo
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	Region Uppsala	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography)		48-96 hours
Primary	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%		up until day 30 day respectively at 48-96 hours
Primary	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		up until day 30 respectively 48-96 hours
Secondary	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%		all time to the first occurrence up until day 30 respectively at 48-96 hours (binary)
Secondary	Randomization 1: Ejection fraction		at 48-96 hours (continuous)
Secondary	Randomization 1: Any sustained ventricular tachycardia or fibrillation		within 48-96 hours (binary)
Secondary	Randomization 1: Any high-grade atrioventricular block or sinus arrest		within 48-96 hours (binary)
Secondary	Randomization 1: Need for cardiac assist device		up until day 30 day (binary)
Secondary	Randomization 1: Death		up until day 30 (binary)
Secondary	Randomization 1: Stroke		up until day 30 (binary)
Secondary	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)		up until day 30
Secondary	Randomization 2: Presence of cardiac thrombus		at 48-96 hours
Secondary	Randomization 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major		up until day 30 (binary)
Secondary	Randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5		up until day 30 (binary)
Secondary	Randomization 2: BARC grade 3-5		up until day 30 (binary)
Secondary	Randomization 2: Any blood transfusion		up until day 30 (binary)