Pharmacological Postconditioning During the Aortic Valvular Surgery

Phase 3

Completed

• Conditions: Aortic Valvular Surgery
• Interventions: Drug: cyclosporine A; Other: No injection

• Registration Number: NCT00987207
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-11
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyclosporine	cyclosporine A	A single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping
Control	No injection	No cyclosporine A is administered before aortic cross-declamping

Primary Outcome Measures

Name	Time	Method
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.	72 hours

Secondary Outcome Measures

Name	Time	Method
Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE	72 hours

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Lyon, France