Multi-centre randomised controlled trial of angiotensin converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) withdrawal in advanced renal disease: the STOP-ACEi trial

Hull University Teaching Hospitals NHS Trust0 个研究点目标入组 411 人开始时间: 2014年2月25日最近更新: 2023年1月9日

适应症

试验速览

•1. Aged =18 years (male or female)
•2. CKD stage 4 or 5 (eGFR <30 ml/minute using the MDRD equation) and not on dialysis therapy
•3. Progressive deterioration in renal function (fall in eGFR of >2 ml/min/year over previous 12-24 months) as measured by linear regression analysis. A simple excel spreadsheet for calculation of this will be provided to all sites. A minimum of 3 measurements of eGFR over the previous 12-24 months are required to identify a >2 ml/min/year fall. The last eGFR must be within 3 months of randomisation
•4. Treatment with either an ACEi or ARB, or a combination of both, for >6 months with at least 25% of the maximum recommended daily dose on the day of consent
•5. Resting blood pressure (BP) =160/90 mmHg when measured in accordance with British Hypertension Society guidelines in clinic or home blood pressure readings within the previous month or a 24 h ambulatory blood pressure measurement within the last 3 months are acceptable
•6. At least 3 months of specialist renal follow-up at the time of entry into the trial
•7. Written, signed informed consent to the trial

•1. Aged <18 years
•2. Uncontrolled hypertension (>160/90 mmHg) or requirement for 5 or more agents to control BP
•3. Undergoing dialysis therapy
•4. Any condition which, in the opinion of the investigator, makes the participant unsuitable for trial entry due to prognosis/terminal illness with a projected survival of less than 12 months
•5. History of myocardial infarction or stroke in preceding 3 months
•6. Participation in an interventional research study in preceding 6 weeks
•7. Pregnancy, confirmed by positive pregnancy test, or breastfeeding
•8. Inability to provide informed consent (e.g. due to cognitive impairment)
•9. Immune-mediated renal disease requiring disease-specific treatment
•10. Known drug or alcohol abuse
•11. Inability to comply with the trial schedule and follow-up

发起方