ACHIEVE-UK

The Oxford Clinical Trials Unit is preparing a grant application to the British Heart Foundation (BHF) for a trial of a drug (spironolactone) in HD patients. They want to do something very like what we have done with Cambridge (SIMPLIFIED), with provision of files containing BP and potassium data) for consented patients. This is what we agreed...

I envisage that:

1. we would send you a list of everyone who has consented to flagging in the registry (and their date of consent) weekly during the recruitment phase (upto 2 years), and we also send you ad-hoc updates if anyone were to withdraw consent subsequent to this during follow-up (which I hope would be almost none)
2. potassium data would then be sent daily to Oxford from the registry (using the systems you have been developing for Cambridge) during the full duration of the trial (5 calendar years if all goes to plan – median participant follow-up 4 years)
3. data on blood pressure and RRT modality would be sent from the UKRR to Oxford less frequently (perhaps 3 monthly?)