Intracoronary administration of levosimendan in cardiac surgery patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002643-10-FI

Enrollment

Registered

2011-12-13

Start date

2012-01-17

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass (AVR+CABG) operation.

Interventions

Trade Name: Simdax Pharmaceutical Form: Infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intracor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are: a)preoperative LVEF 40% or less; b) septal wall thickness more than 11mm; c) less than moderate aortic insufficiency and d) sinus rhythm before cardiopulmonary bypass 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria are oesophageal disease and known allergy to levosimendan or its matabolites or adjuvants.

Design outcomes

Primary

Measure	Time frame
Main Objective: We hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass (CPB) compared to the baseline (after induction of anesthesia).;Secondary Objective: ;Primary end point(s): Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).	—

Measure

Time frame

Main Objective: We hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass (CPB) compared to the baseline (after induction of anesthesia).;Secondary Objective: ;Primary end point(s): Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).

—

Secondary

Measure	Time frame
Secondary end point(s): 15 min after separation from cardiopulmonary bypass;Timepoint(s) of evaluation of this end point: Secondary endpoints are a change in LV ejection fraction from baseline ((after induction of anesthesia) to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026