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

Recruiting now · Phase 4

Conditions studied: Takotsubo Syndrome

In brief

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.

Key facts

Study ID

NCT04666454

Run by

Vastra Gotaland Region

People needed

1000

Starts

2020-12-14

Expected to finish

2028-12-01

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
• Written informed consent obtained

You may not qualify if…

• Previous randomization in the trial
• Any concomitant condition resulting in a life expectancy of less than one month
• Previously diagnosed left ventricular ejection fraction <50%
• Known cardiomyopathy (except previous Takotsubo syndrome)
• Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
• Heart transplant or left ventricular assist device recipient
• Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
• Systolic blood pressure <80 mm Hg at screening
• Estimated glomerular filtration rate <30 mL/min/1.73m2
• Current dialysis
• Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
• 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
• 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)
• 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 %)
• Ongoing treatment with dipyridamole
• Declined participation in study 1
• Specific exclusion criteria for Randomization 2
• Any contra-indication for anticoagulant treatment.
• Current indication for treatment with, anticoagulant or dual antiplatelet therapy
• Declined participation in study 2

Where it is running

• Aarhus Universitetshospital — Aarhus, Denmark (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• Östersund Sjukhus — Östersund, Jämtland Härjedalen, Sweden (enrolling)
• Region Jönköpings Län — Jönköping, Region Jönköping, Sweden (enrolling)
• Norra Älvsborgs länssjukhus — Trollhättan, Västra Götalands Region, Sweden (enrolling)
• Region Dalarna — Falun, Sweden (enrolling)
• Sahlgrenska University Hospital, Department of Cardiology — Gothenburg, Sweden (enrolling)
• Skaraborg Hospital — Gothenburg, Sweden (enrolling)
• Region Skane Helsingborg Hospital — Helsingborg, Sweden (enrolling)
• Region Oestergoetland — Linköping, Sweden (enrolling)
• Region Skane - Skanes Universitetssjukhus — Lund, Sweden (enrolling)
• Region Orebro lan — Örebro, Sweden (enrolling)
• Danderyds Hospital, Department of Cardiology — Stockholm, Sweden (enrolling)
• Karolinska University Hospital, Huddinge, Department of Cardiology — Stockholm, Sweden (enrolling)
• Umeå University Hospital, Department of Cardiology — Umeå, Sweden (enrolling)

Full record on ClinicalTrials.gov

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