Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT04179604
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Written informed consent
* LVEF ≤35% detected by echocardiography carried out at least one week before surgery.
* Scheduled AVR or/and Scheduled CABG with CBP.
Exclusion Criteria:
* Previous levosimendan administration.
* Emergency operation.
* Kidney or liver trasplant or awaiting it.
* Hepatic cirrhosis Child C. In case Child B, contact coordinating center.
* Any degree of preoperative right ventricular failure.
* Preoperative creatinine \> 2 mg / dl.
* Valve desease other than aortic.
* Renal failure requering dialysis (or creatinine clearance \< 30ml / min).
* Hemodynamic instability (need for inotropics, unstable angina, acute myocardial infarction, intra-aortic balloon pump).
* Patients underwent previous cardiac surgery.
* Allergy or hypersensitivity to levosimendan or any of its excipients
* Severe hypotension (sistolic arterial tension \< 80 mmHg or mean arterial pressure \<50 mmHg ) and tachycardia ( heart rate \>130 bpm).
* History of Torsades de Pointes.
* Pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04179604
Study Brief:
Protocol Section:
NCT04179604