Pharmacological Postconditioning During the Aortic Valvular Surgery (PC Pharma CVA)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Aortic Valvular Surgery

Treatments: Drug: cyclosporine A; Other: No injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00987207

2007.490

Details and patient eligibility

About

Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or females, scheduled for an aortic valvular surgery;
• 18 years of age or older.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

cyclosporine

Experimental group

Description:

A single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping

Treatment:

Drug: cyclosporine A

Control

Other group

Description:

No cyclosporine A is administered before aortic cross-declamping

Treatment:

Other: No injection