Pharmacological Postconditioning During the Aortic Valvular Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987207

Acronym

PC Pharma CVA

Enrollment

Registered

2009-09-30

Start date

2008-10-31

Completion date

2010-09-30

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valvular Surgery

Keywords

Postconditioning, cyclosporine A, myocardial ischemia, cardiac surgery, aortic valvulopathy

Brief summary

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

Interventions

DRUGcyclosporine A

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

OTHERNo injection

No cyclosporine A is administered before aortic cross-declamping.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026