Clinical trial NCT00235287: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
Official title: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Cardiovascular Diseases
Keywords: Angiotensin-Converting Enzyme Inhibitors
type 1 angiotensin receptor antagonists
blood pressure
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.


Eligibility criteria: Inclusion Criteria:

* Creatinine: 150-350 micromol/L
* Blood pressure \> 110 systolic
* Negative pregnancy test for fertile women
* Written and oral informed consent from the patient

Exclusion Criteria:

* Treatment with both ACE-inhibitors (ACE-I) and angiotensin receptor blockers
* Pregnancy or breastfeeding
* Treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
* Serious chronic heart failure (New York Heart Association \[NYHA\] III-IV)
* Chronic liver disease
* Suspicion or verified kidney artery stenosis
* Cardiac arrhythmia and/or implanted pacemaker
* Myocardial infarction or cerebrovascular incidence within the last 3 months
* Allergy towards ACE-I or angiotensin receptor blockers
* Amputation of a whole extremity or the crural or femoral part of the leg
* Dementia or a psychological condition that makes understanding of the examination conditions impossible
* Dialysis or renal transplantation
* Treatment with aldosterone antagonists
* Hyperkalemia \> 5.5 mmol/l
* Another serious chronic non-renal disease

Primary outcomes:
measure: pulse wave velocity (aortic and brachial)
timeFrame: 0, 8, 16 and 24 weeks after start of intervention
Secondary outcomes:
measure: augmentation index
timeFrame: 0, 8, 16 and 24 weeks after start of intervention
measure: blood pressure (brachial and aortic)
timeFrame: 0, 8, 16 and 24 weeks after start of intervention
measure: buckbergs index
timeFrame: 0, 8, 16 and 24 weeks after start of interven
measure: time to reflection
timeFrame: 0, 8, 16 and 24 weeks after start of interven
measure: pulse pressure
timeFrame: 0, 8, 16 and 24 weeks after start of interven
measure: change in glomerular filtration rate (GFR)
timeFrame: 0, 8, 16 and 24 weeks after start of interven
measure: blood parameters
timeFrame: at start of intervention and after each 2.5 - 3.week in the study period
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. of Nephrology, Herlev University Hospital
Study officials:
affiliation: Dept. of Nephrology, Herlev University Hospital
name: Marie Frimodt-Møller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frimodt-Moller M, Kamper AL, Strandgaard S, Kreiner S, Nielsen AH. Beneficial effects on arterial stiffness and pulse-wave reflection of combined enalapril and candesartan in chronic kidney disease--a randomized trial. PLoS One. 2012;7(7):e41757. doi: 10.1371/journal.pone.0041757. Epub 2012 Jul 31.