Woman and Man
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Extract
Background and study aims Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of kidney function regardless of the original kidney disease. CKD can have serious effects for those affected, including a risk of CKD progressing to complete kidney failure so that replacement of kidney function by dialysis or transplantation is required. Kidney disease is expensive with a high proportion of the health-care budget spent on CKD; the cost of dialysis alone is about £30,000 per year. Patient quality of life can be poor, with dialysis leading to early death. Treating high blood pressure (BP) is the most important intervention that can slow CKD progression. Some people with CKD gain additional protection from a type of drug, Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by other means. However, recent research suggests that in some people with advanced CKD (stages 4 & 5) who are progressing to complete kidney failure and are receiving treatment with an ACEi and/or ARB, stopping these drugs leads to stabilisation and improvement of kidney function and decreases or delays the need for dialysis. This indicates that in some patients the very tablets used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism. To date, research on this is observational and a study to confirm the association between stopping these drugs and stabilisation of kidney function is required. In this study we will randomly allocate suitable participants to either continue or stop their ACEi/ARB treatment and follow-up participants for 3 years. This study is needed before this treatment strategy can be put into routine clinical practice. In addition, we will look at the other effects of stopping these drugs such as cardiovascular effects and participant quality of life. Who can participate? Men and women, aged 18 years and older, diagnosed with chronic kidney disease. What does the study involve? Participants will be randomly allocated to either continue or discontinue their ACEi and/or ARB treatment. What are the possible benefits and risks of participating? Participants in research studies such as this receive very close monitoring, which will be advantageous to their general health. Although participants may not receive any individual benefit from taking part in the study, the information we get from the study may help us to improve the treatment of all people in the UK with stage 4 or 5 CKD in the future. It is not currently known whether treating people with advanced CKD with ACEi and/or ARBs is beneficial or not. For participants that are allocated to continue with their current ACEi and/or ARB treatment, there will be no additional risk in the study than would normally be encountered in routine clinical care, but if the assumption of this study is correct, there is the risk that the participants CKD may get worse by staying on ACEi and/or ARBs. For participants that are allocated to the discontinuation group, there is the risk that stopping their existing ACEi and/or ARB treatment will cause a loss of the protective effect of ACEi and/or ARBs and an increase in blood pressure. To counteract the loss of antihypertensive therapy (drugs to lower blood pressure), participants that stop their ACEi and/or ARBs will start alternative antihypertensive drugs (e.g. calcium channel blockers, diuretics etc). However, we recognise that drug withdrawal requires close monitoring and the potential risk of increased cardiovascular events for participants will be carefully assessed throughout the study by the Date Monitoring and Ethics Committee. If the results of the study show a benefit for ACEi/ARB withdrawal, it could have a huge impact on patients, their families and health services, by reducing or delaying the need for dialysis and kidney transplantation. We have worked to minimise risk by ensuring that patients are closely monitored and that blood pressure is controlled by alternative means throughout the study. If the treating clinician feels that ACEi/ARB is required, this will be permitted. In patients with advanced CKD there are theoretical reasons why ACEi/ARB may be useful, useless or harmful. In practice, some clinicians withdraw these agents in patients with advanced CKD but others do not. It is important for care of patients that controversy and debate evolves into evidence-based guidelines. Where is the study run from? The study will be run at about 20 sites in Britain. For an up-to-date list of hospitals taking part in the study, please see the study website www.birmingham.ac.uk/STOPACEi When is the study starting and how long is it expected to run for? April 2014 to April 2016 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? [email protected]
Inclusion criteria
- Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal