Table 2.
Exclusion criteria
| 1. | Recent (< 2 months ago): myocardial infarction, coronary revascularization, surgery or catheter intervention for valvular heart disease, acute coronary syndrome, stroke or cerebral ischaemia, start of heart failure device therapy potentially improving left ventricular ejection fraction or heart failure symptoms (e.g. cardiac resynchronization therapy, cardiac contractility modulation, baroreflex activation therapy) |
| 2. | Scheduled surgery or catheter intervention for valvular heart disease or scheduled coronary revascularization |
| 3. | Active myocarditis |
| 4. | Complex congenital heart disease; this does not include: mild‐moderate valve disease, uncomplicated shunts (isolated patent foramen ovale, small atrial or ventricular septum defects without associated lesions), repaired secundum or sinus venosus atrial septal defects or ventricular septal defects without residua, previously ligated or occluded ductus arteriosus |
| 5. | High‐urgency listing for heart transplantation or scheduled therapy with left ventricular assist device |
| 6. | Heart rate < 60 b.p.m. (except if functional cardiac resynchronization therapy in place) |
| 7. | Sinoatrial/atrioventricular block >I degree, sick sinus syndrome or carotid sinus syndrome (except if pacemaker protected) |
| 8. | Proven or suspected accessory, atrioventricular pathways (e.g. Wolff–Parkinson–White syndrome) |
| 9. | History of symptomatic or sustained (≥ 30 s) ventricular arrhythmia unless a cardioverter‐defibrillator implanted |
| 10. | Current ventricular tachycardia or fibrillation (this means patients presenting with a running ventricular tachycardia or fibrillation. If ventricular arrhythmias are terminated and a cardioverter‐defibrillator is implanted, inclusion is allowed according to point 9) |
| 11. | Hypertrophic obstructive cardiomyopathy (idiopathic subaortic stenosis) |
| 12. | Cor pulmonale |
| 13. | Constrictive pericarditis |
| 14. | Thoracic aortic aneurysm (defined as diameter ≥ 45 mm) |
| 15. | Concomitant severe liver and renal disease |
| 16. | Persistent hypokalaemia (< 3.2 mM) |
| 17. | Hypercalcaemia or hypomagnesaemia, if clinically suspected and verified by laboratory testing (e.g. hyperparathyroidism, neoplasia‐induced hypercalcaemia, signs of neuromuscular hyperexcitability) |
| 18. | Present (within 6 weeks before baseline/day 0 visit) and continuous treatment with amiodarone [single or short‐term (up to 3 days), not continuous administration of amiodarone immediately before or during study treatment are acceptable] |
| 19. | Scheduled DCC in the next 24 h (e.g. patients not on cardiac glycosides with new‐onset atrial fibrillation. Patients already included and on treatment with IMP can continue IMP and study when scheduled for DCC) |
| 20. | Presence of both treatment with cardiac glycosides and atrial fibrillation |
| 21. | Simultaneous intravenous treatment with calcium salts |
| 22. | Evidence of cardiac glycoside intolerance or known hypersensitivity to any component of IMP |
| 23. | Suspected intoxication with cardiac glycosides |
| 24. | Unlikely compliance with protocol requirements |
| 25. | Pregnant and lactating women |
| 26. | Use of other investigational drugs or devices at the time of enrolment, or within 30 days prior to enrolment or 5 half‐lives for investigational drugs, whichever is longer |
| 27. | Life expectancy < 12 months (e.g. due to active cancer) |
DCC, direct current cardioversion; IMP, investigational medicinal product.