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

What this Trial Is About

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.

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