Status:
COMPLETED
Pharmacological Postconditioning During the Aortic Valvular Surgery
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Aortic Valvular Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.
Eligibility Criteria
Inclusion
- Male or females, scheduled for an aortic valvular surgery;
- 18 years of age or older.
Exclusion
- Combined valvular and coronary surgery;
- Significant coronary artery stenosis (upper than 70%);
- Left ventricular dysfunction (ejection fraction \< 40%);
- Emergency surgery and/or infectious endocarditis;
- Known cyclosporin hypersensitivity;
- History of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis;
- Renal insufficiency (creatininaemia \> 150 µmol/l);
- Hepatic insufficiency (prothrombin time \< 50%);
- Uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm Hg;
- Women of child bearing potential, who are pregnant or not under efficient contraception;
- Patients treated with nicorandil, sulfonylurea or rosuvastatine;
- Patients under judicial control.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00987207
Start Date
October 1 2008
End Date
September 1 2010
Last Update
May 28 2019
Active Locations (1)
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1
Hôpital Louis Pradel
Lyon, France, 69394