Table 1.
Established and Emerging Therapeutic Indications for Levosimendan Assessed in Ongoing or Completed Studies Retrieved from Clinicaltrials.gov (as of 09th March 2021)
| Therapeutic Indications | No. of Retrieved Studies | Dose | Setting | Comparator | Status | ||||
|---|---|---|---|---|---|---|---|---|---|
| Acute | Inpatients | Outpatients | None (Single Arm) | Placebo | Active | ||||
| Cardiogenic shock/Acute heart failure | 42 | 0.05–0.4 µg/kg/min for 24 hours | 32 | 5 | 5 | 13 | 21 | 2 Dobutamine 2 Milrinone 2 Usual care 1 Inotropes 1 Intra-aortic balloon pump |
16 Completed 9 Unknown 8 Recruiting 4 Not yet recruiting 4 Terminated 1 Enrolling by invitation |
| Pre-emptive administration in non-cardiac surgery | 6 | 0.1–0.2 µg/kg/min for 24 hours | 6 | - | - | 1 | 3 | 2 Dobutamine | 2 Completed 2 Unknown 1 Recruiting 1 Withdrawn |
| Valve surgery | 6 | 0.1–0.2 µg/kg/min for 24 hours | 6 | - | - | 1 | 4 | 1 Dobutamine | 3 Completed 2 Terminated 1 Recruiting |
| Septic shock | 5 | 0.2 µg/kg/min for 24 hours | 5 | - | - | 1 | - | 3 Dobutamine 1 Norepinephrine + Milrinone |
3 Unknown 1 Completed 1 Recruiting |
| Pulmonary hypertension | 4 | 3–12 µg/kg | 2 | - | 2 | 2 | 1 | 1 Milrinone | 2 Recruiting 1 Completed 1 Active not recruiting |
| Amyotrophic lateral sclerosis | 3 | 1–2 mg/day | - | - | 3 (oral) | 1 | 2 | - | 3 Completed |
| Low cardiac output syndrome in paediatric setting | 3 | 0.1–0.2 µg/kg/min for 24 hours | 3 | - | - | - | 2 | 1 Milrinone | 3 Completed |
| Acute kidney injury after cardiac surgery | 3 | LD 12 µg/kg in 30 minutes MD 0.1–0.2 µg/kg/min for 24 hours |
3 | - | - | - | 1 | 1 Milrinone 1 Conventional therapy |
2 Completed 1 Unknown |
| Cardiac surgery in paediatric setting | 3 | 0.1 µg/kg/min for 24 hours | 3 | - | - | - | - | 2 Milrinone 1 Magnesium sulphate |
1 Completed 1 Unknown |
| Muscle weakness conditions | 2 | 0.2 µg/kg/min for 7 hours | - | 2 | - | 1 | 1 | - | 2 Unknown |
| Cardiorenal syndrome in heart failure | 2 | LD 12 µg/kg over 10 minutes MD 0.1 µg/kg/min over 65 minutes |
2 | - | - | 1 | - | 1 Dobutamine | 1 Completed 1 Unknown |
| Chronic heart failure | 2 | 0.2 µg/kg/min for 6 hours NA (oral dosage) |
- | 1 | 1 (oral) | 1 | 1 | - | 2 Completed |
| Pharmacokinetics in special populations | 2 | NA | 2 | - | - | 2 | - | - | 1 Recruiting 1 Unknown |
| ECG variables | 1 | 0.125–2 mg | - | - | 1 (oral) | - | 1 | - | 1 Completed |
| Respiratory muscle function in healthy subjects | 1 | NA | - | - | 1 | 1 | - | - | 1 Completed |
| Acute respiratory distress syndrome | 1 | 0.1–0.2 µg/kg/min for 24 hours | 1 | - | - | 1 | - | - | 1 Recruiting |
Abbreviations: ECG, electrocardiogram; LD, loading dose; MD, maintenance dose; NA, not available.