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OpenTrials
Completed

NCT Number: NCT00987207

Pharmacological Postconditioning During the Aortic Valvular Surgery

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

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Key information

Conditions

Aortic Valvular Surgery Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Louis Pradel

Lyon, 69394, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclosporine A

Drug

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

No injection

Other

No cyclosporine A is administered before aortic cross-declamping.

Primary outcomes

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

    Time frame: 72 hours

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PC Pharma CVA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2009
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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