Angiotensin II receptor blockers (ARB) are known to preserve kidney function among patients with kidney diseases and reduced renal function, but not among haemodialysis patients. Haemodialysis patients often lose residual renal function after initiating dialysis leading to worsened quality of life, increased morbidity and mortality. In this study an ARB is investigated in a double blind, randomised, parallel group, placebo controlled manner to see, if this ARB can save residual renal function among haemodialysis patients. Potential cardiovascular benefits of the treatment are also addressed.
Haemodialysis patients often lose residual renal function rather quickly after initiation of dialysis - average loss is 30 % per year. Loss of residual kidney function leads to deteriorating quality of life, more morbidity and a higher mortality. Many causes to this has been identified, but no one has - to my knowledge - addressed saving of residual renal function among haemodialysis patients so far. Hypothesis: Irbesartan can reduce loss of residual kidney function among haemodialysis patients and left ventricular hypertrophy and arterial stiffness is less pronounced after 1 year of treatment. Methods: 80 patients are randomised to receive either irbesartan, an angiotensin II receptor blocker (ARB), or placebo for 1 year. Residual renal function will be estimated before and one-two weeks after initiating project medicine, in order to estimate the acute effect of ARB on residual renal function in this study population. Thereafter, glomerular filtration rate (GFR) and urine volume will be determined after 3, 6, 9 and 12 months giving a regression line for each patient. 8 dialysis units will be recruiting patients. Investigations: * creatinine-urea-clearance by 24h urine collection * applanation tonometry * cardiac output * echocardiography * QoL questionnaire * endocrinological and cardiovascular markers in blood and urine Perspectives: It is well-known that ceased urine production has a tremendous negative effect on the quality of life of haemodialysis patients. Lately it was shown that residual renal function has greater impact than dialysis dose on morbidity as well as mortality. Among peritoneal dialysis patients in Asia an angiotensin-converting enzyme inhibitors (ACEI) or an ARB saved residual renal function, but preservation of renal function has not been addressed in haemodialysis patients, and ACEI or ARB are only prescribed to roughly 15 % of these. If this study confirms our hypothesis the growing population of haemodialysis patients should be offered irbesartan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
82
Tablets, 300 mg \* 1 daily, 1 year
Tablets, 300 mg \* 1 daily, 1 year
Department of Nephrology, Aarhus University, Aalborg
Aalborg, Denmark
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, Denmark
Department of Medicine, Fredericia Hospital
Fredericia, Denmark
Haemodialysis unit, Horsens Hospital
Horsens, Denmark
Hemodialysis Unit, Randers Hospital
Randers, Denmark
Department of Medicine M, Viborg Hospital
Viborg, Denmark
Decrease in loss of residual kidney function.
Time frame: 3, 6, 9 and 12 months
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
Time frame: 1 year
Progression to anuria
Time frame: 3, 6, 9 and 12 months
Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)
Time frame: 1 year
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