Takotsubo syndrome (TTS), also known as apical ballooning syndrome, Takotsubo cardiomyopathy, broken heart syndrome, and stress-induced cardiomyopathy, is a rare condition and accounts for 1–3% of all patients referred to hemodynamic laboratories with a primary diagnosis of acute coronary syndrome (ACS). MedDRA version: 20.1 Level: LLT Classification code 10067676 Term: Takotsubo syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Simdax
Product Name: Simdax
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levosimendan
CAS Number: 141505-33-1
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Medical University of Gdansk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 -Signed informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: 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 2 mmol/L) 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 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess whether the use of levosimendan in TTS improves LVEF in TTE 72 ± 3 hours after the end of the levosimendan infusion (primary primary endpoint).;Secondary Objective: Clinical benefit will be defined as a reduction in the incidence of adverse major cardiovascular events such as all-cause death, TTS recurrence or worsening heart failure leading to unscheduled hospitalization, stroke or TIA (major secondary endpoint) over the 12-month follow-up period.;Primary end point(s): The primary objective of the study is to assess whether the use of levosimendan in TTS improves LVEF in TTE 72 ± 3 hours after the end of the levosimendan infusion (primary primary endpoint).;Timepoint(s) of evaluation of this end point: 72 ± 3 hours after completion of the levosimendan infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Composite endpoint of 12-month all-cause mortality or proportion of major cardiovascular events (rehospitalization for recurrent TTS or heart failure, stroke or TIA, whichever comes first), all-cause mortality, re-hospitalization hospitalization due to recurrent TTS or heart failure, stroke or TIA, length of hospitalization, need for inotropic treatment, functional capacity (NYHA class), decrease in B-natriuretic peptide level.;Timepoint(s) of evaluation of this end point: 12 months (ongoing evaluation) | — |
Countries
Poland
Contacts
Public ContactPiotr Widlak
Biuro „Centrum Wsparcia Badan Klinicznych Gdanskiego Uniwersytetu Medycznego”
Outcome results
None listed