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History of Changes for Study: NCT04666454
BROKEN-SWEDEHEART-Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome
Latest version (submitted December 28, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 7, 2020 None (earliest Version on record)
2 March 12, 2021 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Study Design
3 January 17, 2022 Outcome Measures, Study Status, Contacts/Locations and Arms and Interventions
4 May 2, 2023 Study Status and IPDSharing
5 December 28, 2023 Contacts/Locations, Study Status, Study Identification, Study Design, Sponsor/Collaborators and Eligibility
Comparison Format:
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Study NCT04666454
Submitted Date:  December 7, 2020 (v1)
Open or close this module Study Identification
Unique Protocol ID: 2020-002708-38
Brief Title: BROKEN-SWEDEHEART-Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome
Official Title: Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: July 2024 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: December 7, 2020
First Submitted that
Met QC Criteria:		 December 7, 2020
First Posted: December 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 December 7, 2020
Last Update Posted: December 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vastra Gotaland Region
Responsible Party: Sponsor
Collaborators: Sahlgrenska University Hospital, Sweden
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Takotsubo Syndrome
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Factorial Assignment
Multinational, multicentre, registry-based, open-label, randomized controlled trial with 2 × 2 factorial design
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Randomisation 1: Adenosine and Dipyridamole
Adenosine infusion 70 µg/kg/min for 3 hours, followed (first dose 24 hours 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 72 hours or at any subsequent echocardiographic examination, or for 30 Days.
 Drug: Adenosine
Adenosine infusion 70 µg/kg/min for 3 hours.
Drug: Dipyridamole 200 mg
200 mg b.i.d
Randomisation 1: Control
Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.
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.
Active Comparator: Randomisation 2: Apixaban
Apixaban 5mg b.i.d. per oral until normalization of LV function (EF≥50%) is documented on the study-specific echocardiographic assessment at 72 hours or any subsequent echocardiographic examination, or for 30 Days.
 Drug: Apixaban 5 mg Oral Tablet
5mg b.i.d
No Intervention: Randomisation 2: No anticoagulant therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Randomisation 1:The occurrence of the composite of death, cardiac arrest (defined as ventricular fibrillation or asystole >30 seconds), or the need for cardiac mechanical assist device
[ Time Frame: within 30 days ]
2. Randomisation 1:The occurrence of ejection fraction <50%
[ Time Frame: at 72 hours ]
3. Randomisation 1:The occurrence of re-hospitalization for heart failure
[ Time Frame: within 30 days ]
4. Randomisation 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction)
[ Time Frame: within 30 days ]
5. Randomisation 2: The occurrence of death
[ Time Frame: within 30 days ]
6. Randomisation 2: The presence of a cardiac thrombus
[ Time Frame: at 72 hours ]

as assessed by echocardiography
Secondary Outcome Measures:
1. Randomisation 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%
[ Time Frame: all time to the first occurrence within 30 days respectively 72 hours (binary) ]
2. Randomisation 1: Ejection fraction
[ Time Frame: at 72 hours (continuous) ]
3. Randomisation 1: Any ventricular tachycardia or fibrillation
[ Time Frame: within 72 hours (binary) ]
4. Randomisation 1: Any high-grade atrioventricular block or sinus arrest
[ Time Frame: within 72 hours (binary) ]
5. Randomisation 1: Need for cardiac assist device (binary)
[ Time Frame: within 30 days ]
6. Randomisation 1: Death
[ Time Frame: within 30 days ]
7. Randomisation 2: Presence of cardiac thrombus
[ Time Frame: at 72 hours ]
8. Randomisation 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major
[ Time Frame: within 30 days (binary) ]
9. Randomisation 2: Bleeding Academic Research Consortium (BARC) grade 2-5
[ Time Frame: within 30 days ]
10. Randomisation 2: BARC grade 3-5
[ Time Frame: within 30 days (binary) ]
11. Randomisation 2: Any blood transfusion (binary)
[ Time Frame: within 30 days ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. A clinical diagnosis of Takotsubo syndrome (TS)
  3. Written informed consent obtained

Exclusion Criteria:

  1. Previous randomization in the study
  2. Any contra-indication for treatment with adenosine or dipyridamole (AV-block II and III, sick sinus syndrome in patients who do not have a functioning pacemaker, unstable angina)
  3. Ongoing treatment with dipyridamole
  4. Any concomitant condition resulting in a life expectancy of less than one month
  5. Previously diagnosed left ventricular ejection fraction <40%
  6. Known cardiomyopathy
  7. Hemodynamically significant valve disease
  8. Most recent haemoglobin <10 g/dL
  9. Heart transplant or left ventricular assist device recipient
  10. Systolic blood pressure <80 mm Hg at screening
  11. Estimated glomerular filtration rate <30 mL/min/1.73m2
  12. Current dialysis
  13. Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
  14. 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 subject exclusion criteria (Randomisation 2)

  1. Any contra-indication for anticoagulant treatment.
  2. Ongoing treatment with, or current indication for treatment with, anticoagulant or dual antiplatelet therapy.
Open or close this module Contacts/Locations
Central Contact Person: Elmir Omerovic, MD PhD
Telephone: 31 3421000 Ext. +46
Email: elmir@wlab.gu.se
Central Contact Backup: Björn Redfors, MD, PhD
Telephone: 31 3421000 Ext. +46
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
To be decided.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame:
To be decided
Access Criteria:
To be decided (TBD)
URL: https://TBD
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services