What is this study about?
The CARSK trial will enrol people who are already on the kidney transplant waitlist, and who don’t have any symptoms of new heart problems. The patients enrolled will stay in the study for a maximum of 5 years. While they are in the study, participants will be followed up as usual–they will not have to have any extra appointments but will receive a phone call every 6 months to check their waitlist status and exclude any coronary artery disease (CAD) events.
They will also be asked to complete cost and quality of life questionnaires. The trial will use chance to allocate people to either getting no regular heart testing while they wait for a kidney transplant, or to get regular (every year or every second year) heart testing.
We will make sure everyone gets tested if they develop any symptoms of heart problems. The trial will measure what happens to people, and particularly whether they develop any heart problems, whether they get a kidney transplant, and whether they have any heart problems after a transplant.
Why is this study important?
The study is important as we know the most common cause of death for people on dialysis or after a transplant is heart related. We don’t know if finding heart disease and trying to treat it early, before it is bothering people, is a good idea–-even though this is what is done at the moment. We think testing and treating people who don’t have symptoms might cause more problems than it solves--it might remove them from the waitlist unnecessarily, or put them through tests and procedures or operations that they don’t really need, and waste a lot of peoples’ time and money without good reason.
This CARSK study will help us work out whether regular testing is helpful, by showing us whether there is any difference to what happens to people if they are tested or not. The study investigators think it is likely that there will be no difference, so we have used best scientific principles to design the CARSK study to test whether we are right.