Cardiovascular Diseases, Kidney Failure, Chronic
Conditions
Keywords
Angiotensin-Converting Enzyme Inhibitors, type 1 angiotensin receptor antagonists, blood pressure
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.
Interventions
DRUGCandesartan and enalapril
24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.
DRUGcandesartan and enalapril
24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pulse wave velocity (aortic and brachial) | 0, 8, 16 and 24 weeks after start of intervention |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure (brachial and aortic) | 0, 8, 16 and 24 weeks after start of intervention |
| buckbergs index | 0, 8, 16 and 24 weeks after start of interven |
| time to reflection | 0, 8, 16 and 24 weeks after start of interven |
| augmentation index | 0, 8, 16 and 24 weeks after start of intervention |
| change in glomerular filtration rate (GFR) | 0, 8, 16 and 24 weeks after start of interven |
| blood parameters | at start of intervention and after each 2.5 - 3.week in the study period |
| pulse pressure | 0, 8, 16 and 24 weeks after start of interven |
Countries
Denmark
Contacts
Primary ContactMarie Frimodt-Møller, MD
Backup ContactArne H Nielsen, MD, Prof.
Outcome results
None listed