Extrait

Background and study aims Chronic kidney disease (CKD) is a major risk factor for heart and blood vessel disease. Mild CKD is surprisingly common, affecting almost 1 in 7 of the population. The adverse cardiovascular (heart) effects of CKD are caused mainly by damage and thickening of the heart muscle and an increase in artery stiffness, which together cause stroke, heart failure and sudden cardiac death. We have previously shown that an old and inexpensive drug called spironolactone reduces the heart thickening and arterial stiffening in CKD compared to an inactive (placebo) tablet. During treatment with spironolactone however, blood pressure fell and it is not clear whether the beneficial effects of this drug on the heart and arteries were caused by this fall in blood pressure or were specific to the effects of spironolactone. The aim of this study is to compare the effects of spironolactone to a different blood pressure lowering drug called chlortalidone on patients with early CKD. Who can participate? Patients aged over 18 with early CKD What does the study involve? Participants are randomly allocated to take either spironolactone or chlortalidone for 40 weeks. Changes in heart muscle weight and arterial stiffness are measured. What are the possible benefits and risks of participating? The results should show whether or not the effects of spironolactone on the arteries and heart in patients with CKD are due to blood pressure lowering alone or are due to the special effects of spironolactone. If the effects are specific to spironolactone and occur over and above the blood pressure lowering effects, the drug may be a very effective and inexpensive way to prevent death and disability due to heart and artery disease in patients with CKD. Where is the study run from? Birmingham Clinical Trials Unit (UK) When is the study starting and how long is it expected to run for? January 2014 to January 2017 Who is funding the study? British Heart Foundation (BHF) (UK) Who is the main contact? Gemma Slinn [email protected]

Critère d'inclusion

• Topic: Cardiovascular, Renal and Urogenital; Subtopic: Cardiovascular (all Subtopics), Renal and Urogenital (all Subtopics); Disease: Cardiovascular, Renal

Liens

• ictrp
• isrctn