Spanish Randomized Clinical Trial on Sindax

Phase 1

• Conditions: Patients who have preoperatively severe left ventricular dysfunction (LVEF = 35%) and will be scheuled for cardiac surgery on cardiopulmonary bypass.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001756-19-ES
• Lead Sponsor: María de los Ángeles Tena Pajuelo (Investigador independiente)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-09
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients 18 years of age or older.
2. Documented ejection fraction of the left ventricle = 35% measured by
echocardiogram within 7 days prior to surgery.
3. Patients scheduled to undergo one of the following cardiac surgery with
extracorporeal circulation of:

1) surgery on the aortic valve, or

2) myocardial revascularization surgery due to ischemic heart disease or

3) the two previous procedures combined.

4. Patients who have signed the informed consent.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1. Previous administration of Levosimendan
2. Emergency operation
3. Previous or pending renal or liver transplantation.
4. Liver cirrhosis: Child C. In the case of Child B, contact the Coordinating Center.
5. Any degree of preoperative right ventricular failure
6. Preoperative creatinine> 2 mg / dl
7. Valvulopathy that is not aortic.
8. Renal impairment with dialysis (or creatinine clearance <30ml / min).
9. Hemodynamic instability (need for inotropics, unstable angina, acute AMI,
use of counterpulsation balloon).
10. Reoperated.
11. Hypersensitivity to levosimendan or any of the excipients.
12. Severe hypotension and tachycardia
13. History of Torsades de Pointes.
14. Pregnancy or Lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified