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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00987207
First received: September 29, 2009
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Aortic Valvular Surgery
 Drug: cyclosporine A
Other: No injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pharmacological Postconditioning During the Aortic Valvular Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyclosporine
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
 Drug: cyclosporine A
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
No Intervention: Control
No cyclosporine A is administered before aortic cross-declamping
 Other: No injection
No cyclosporine A is administered before aortic cross-declamping.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987207

Locations
France
Hôpital Louis Pradel
Lyon, France, 69394
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pascal CHIARI, MD Hospices Civils de Lyon - France
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00987207     History of Changes
Other Study ID Numbers: 2007.490
Study First Received: September 29, 2009
Last Updated: November 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Postconditioning
cyclosporine A
myocardial ischemia
cardiac surgery
aortic valvulopathy

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013