A phase I study to determine the pharmacokinetic profile, safety and tolerability of Sildenafil (REVATIO®) in cardiac surgery

niversity of Leicester (UK)0 个研究点目标入组 36 人开始时间: 2013年6月24日最近更新: 2019年2月11日

适应症

试验速览

•1. Adult cardiac surgery patients (>18 years and <80 years) undergoing cardiac surgery with moderately hypothermic CPB (32-34° C) and blood cardioplegia.
•2. Identified as representing a high risk group for acute kidney injury using a modified risk score.
•3. Female subjects of childbearing potential are not to be pregnant (to be confirmed by urine human chorionic gonadotropin pregnancy test). Women are considered not to be of childbearing potential if they have been surgically sterilised (eg, tubal ligation, oophorectomy or hysterectomy) or are postmenopausal (defined as serum follicle-stimulating hormone level of =30 IU/mL) in the absence of hormone replacement therapy and complete absence of menses for at least 24 consecutive months.
•Target Gender: Male & Female; Upper Age Limit 80 years ; Lower Age Limit 18 years

•1. Emergency or salvage procedure
•2. Ejection fraction <30%
•3. CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy
•4. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation.
•5. Administration of nitrate medicines (e.g. glyceryl trinitrate within 24 hours of surgery.
•6. Any ongoing malignancy, or prior malignancy that currently requires treatment.
•7. Patients allergic to any other PDE-5 Inhibitor.
•8. Patients who are participating in another interventional clinical study.

发起方

niversity of Leicester (UK)