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

Prinicipal Investigator: Professor Gavin Murphy
Study Start: June 2013

Acute kidney injury occurs in up to one third of all patients following cardiac surgery. It is manifested by an acute decline in kidney function and results in significant increases in post-operative complications and death. Globally, the understanding of the underlying processes whereby the disease is established is poor, and recent systematic reviews have concluded that there is not yet an effective treatment.

Lab EquipmentExperimental studies have demonstrated that preservation of Nitric Oxide levels in the tissues protects the kidneys in response to a variety of injurious stimuli. Nitric Oxide activity is increased by administration of the phophodiesterase type 5 (PDE-5) inhibitor sildenafil citrate. This is already used clinically in the treatment of erectile dysfunction (Viagra®, Pfizer) and more recently, pulmonary hypertension and acute right ventricular failure (Revatio®, Pfizer).

Our team has already demonstrated in previous pre-clinical studies that the administration of sildenafil prevents acute kidney injury (AKI) in association with an increase in Nitric Oxide bioavailability. There is a recognised clinical need for prevention and treatment strategies for AKI and we propose to evaluate the pharmacokinetic profile, safety and tolerability of sildenafil and its effect on post-operative kidney function in patients undergoing cardiac surgery who are at increased risk of developing AKI in an open label, dose escalation study.

For more information about the REVAKI study please email Tracy Kumar (Trial Coordinator) or Lathishia Joel-David (Research Nurse)

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