Pharmacological Postconditioning During the Aortic Valvular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Aortic Valvular Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cyclosporine

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

Group Type EXPERIMENTAL

cyclosporine A

Intervention Type DRUG

a single bolus of 2.5 mg/kg, administered before aortic cross-declamping

Control

No cyclosporine A is administered before aortic cross-declamping

Group Type OTHER

No injection

Intervention Type OTHER

No cyclosporine A is administered before aortic cross-declamping.

Interventions

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cyclosporine A

a single bolus of 2.5 mg/kg, administered before aortic cross-declamping

Intervention Type DRUG

No injection

No cyclosporine A is administered before aortic cross-declamping.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No