REVAKI 2: The effect of Sildenafil (Revatio®) on post-cardiac surgery acute kidney injury: a randomised, placebo-controlled Phase IIb clinical trial
Principal Investigator: Professor Gavin Murphy
Kidney damage is a common complication of heart surgery and currently there is no drug or treatment available to prevent this.
Previous research within the Leicester Cardiovascular BRU (now Leicester BRC) has shown that sildenafil (Revatio®) can prevent kidney damage in laboratory settings by improving blood flow to the kidneys.
Sildenafil is already available in the United Kingdom to treat erectile dysfunction (impotence) and a lung condition called pulmonary arterial hypertension. In a previous trial (REVAKI-1) we identified a dose of sildenafil that was safe and resulted in blood levels that are known to be effective for the treatment of these other conditions.
The REVAKI-2 trial aims to compare the extent of kidney damage in patients receiving a dose of Sildenafil (as identified in the REVAKI-1 trial) compared to those receiving a placebo – an inactive ‘dummy’ substance.
This study is a double-blinded design, whereby neither the patient nor their treating doctor knows whether they are receiving the drug or placebo. This is the ‘gold standard’ of study design and will enable us to determine the best treatment without any bias that could influence the outcome of the trial.
Around 126 patients having heart surgery who are at risk of kidney failure will be invited to take part.
As well as being given the drug or the placebo, patients will be asked to give extra blood and urine samples. Apart from this, everything about the operation and their treatment will happen using standard models of care.
For more information about REVAKI-2, contact Tracey Kumar, Cardiac Surgery Research Manager on 0116 258 3039 or email firstname.lastname@example.org
You can read publications based on this work so far here and here.