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Study of Levosimendan Therapy in low ejection fraction Takotsubo Syndrome
EU CTIS ID: 2024-515060-32-00
What this study is testing
To evaluate whether off-label use of levosimendan accelerates in-hospital left ventricular ejection fraction (LVEF) recovery and reduces the 12-month incidence of all-cause mortality or major adverse cardiovascular events (MACE) — including rehospitalization due to Takotsubo syndrome (TTS) recurrence or heart failure, stroke, or transient ischemic attack (TIA) — in patients with TTS and an LVEF ≤40% at admission, compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Age > 60 years - Current hospitalization due to TTS - LVEF as assessed by echocardiography within 24 hours of admission ≤ 40% or decrease in LVEF by ≥ 10% compared to the last documented LVEF value before index hospitalization - NTproBNP concentration ≥ 500 pg/mL
You likely can't join if
- 1. Myocardial infarction within 30 days before randomization 2. Cerebrovascular disease (new stroke, subarachnoid hemorrhage) 3. Diagnosis of pheochromocytoma 4. Diagnosis of myocarditis 5. Low output syndrome - hypotonia with signs of tissue hypoperfusion (systolic blood pressure < 85 mmHg AND lactate > 2 mmol/L) XML File Identifier: oaQaRqf974zsAHLIB5CKhj434nk= Page 10/22 6. Pulmonary edema 7. Echocardiographic evidence of LVOTO 8. Uncontrolled hypertension 9. Planned revascularization or surgical treatment of heart failure within the next 12 months 10. Advanced chronic kidney disease (eGFR < 30 mL/min.) 11. Biochemical features of liver damage (>5 upper limits of reference hepatic aminotransferase activity and/or >3 upper limits of reference total bilirubin level) 12. Severe chronic lung disease with features of respiratory failure [defined as respiratory dysfunction impairing gas exchange and leading to hypoxemia - arterial blood oxygen partial pressure (PaO2) <60mmHg (8.0 kPa) and/or hypercapnia - increase in carbon dioxide partial pressure (PaCO2) ≥45mmHg (6, 0 kPa)] or severe spirometry abnormalities [defined as very severe obstruction, i.e., a decrease in the forced expiratory volume in 1 second (FEV1) <35% of normal value] or home oxygen therapy [in chronic lung disease with features of respiratory failure, indications for home oxygen therapy include: PaO2 ≤55 mmHg (corresponding to saturation ≤88%); PaO2 55-60 mmHg (corresponding to saturation ≤88%); and pulmonary hypertension, peripheral edema suggestive of right heart failure, or polycythemia (hematocrit>55%)]. 13. Concomitant chronic disease with poor prognosis (e.g., cancer) 14. Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia including torsade de pointes, severe atrioventricular block within one month before the study eligibility visit 15. History of hypersensitivity to levosimendan 16. Pregnancy or postpartum period 17. Patients with foreseeable problems cooperating with the medical and nursing team.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.