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Rationale and desig...
Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome.
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- Omerovic, Elmir, 1968 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Sahlgrens Univ Hosp, Sweden,Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
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- James, Stefan, 1964- (author)
- Uppsala universitet,Kardiologi,Uppsala Univ Hosp, Sweden,Uppsala University Hospital
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- Erlinge, David (author)
- Lund University,Lunds universitet,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Molecular Cardiology,Lund University Research Groups,Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden
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- Hagström, Henrik (author)
- Karolinska Institutet,Department of Cardiology, Umeå University Hospital, Umeå, Sweden
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- Venetsanos, Dimitrios (author)
- Karolinska Univ Hosp, Sweden,Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
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- Henareh, Loghman (author)
- Karolinska Institutet,Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
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- Ekenbäck, Christina (author)
- Karolinska Institutet,Danderyd Hospital
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- Alfredsson, Joakim (author)
- Region Östergötland, Kardiologiska kliniken US,Department of Cardiology, Linköping University Hospital, Linköping, Sweden
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- Hambreus, Kristina (author)
- Falun Cent Hosp, Sweden,Falun Central Hospital,Department of Cardiology, Falun Hospital, Falun, Sweden
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- Redfors, Björn (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Sahlgrens Univ Hosp, Sweden,Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
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- Elsevier BV, 2022
- 2022
- English.
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In: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703.
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Abstract
Subject headings
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- Takotsubo syndrome (TS) is a life-threatening acute heart failure syndrome without any evidence-based treatment options. No treatment for TS has been examined in a randomized trial.design and objectives BROKEN-SWEDEHEART is a multicenter, randomized, open-label, registry-based 2 × 2 factorial clinical trial in patients with TS designed to test whether treatment with adenosine and dipyridamole accelerates cardiac recovery and improves clinical outcomes compared to standard care (study 1); and apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (study 2). The trial will enroll 1000 patients. Study 1 (adenosine hypothesis) will evaluate two co-primary endpoints: (1) wall motion score index at 48-96 hours (evaluated in the first 200 patients); and (2) the composite of death, cardiac arrest, need for mechanical assist device or heart failure hospitalization within 30 days or left ventricular ejection fraction <50% at 48-96 hours (evaluated in 1000 patients). The primary endpoint in study 2 (apixaban hypothesis) is the composite of death or thromboembolic events within 30 days or the presence of intraventricular thrombus on echocardiography at 48-96 hours.BROKEN-SWEDEHEART will be the first prospective randomized multicenter trial in patients with TS. It is designed as two parallel studies to evaluate whether adenosine accelerates cardiac recovery and improves cardiac function in the acute phase and the efficacy of anticoagulation therapy for preventing thromboembolic complications in TS. If either of its component studies is successful, the trial will provide the first evidence-based treatment recommendation in TS.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- Acute heart failure
- Broken heart syndrome
- Takotsubo syndrome
- Takotsubo syndrome; Acute heart failure; Broken heart syndrome
- Acute heart failure
Publication and Content Type
- ref (subject category)
- art (subject category)
- By the author/editor
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Omerovic, Elmir, ...
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James, Stefan, 1 ...
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Erlinge, David
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Hagström, Henrik
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Venetsanos, Dimi ...
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Henareh, Loghman
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Ekenbäck, Christ ...
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Alfredsson, Joak ...
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Hambreus, Kristi ...
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Redfors, Björn
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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American heart j ...
- By the university
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University of Gothenburg
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Uppsala University