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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacodynamics Study

Intervention(s) in this Clinical Trial

• Drug: candesartan/Atacand and enalapril

Primary Measures

• pulse wave velocity (aortic and brachial)

Secondary Measures

• augmentation index
• blood pressure (brachial and aortic)
• buckbergs index
• time to reflection
• pulse pressure
• change in glomerular filtration rate (GFR)
• blood parameters
• etc.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Herlev Hospital

Overall Clinical Trial Officials and Contacts

Marie Frimodt-Møller, MD Principal Investigator Dept. of Nephrology, Herlev University Hospital  

Overall Contact: Marie Frimodt-Møller, MD + 45 44 88 44 88 marfri01@heh.regionh.dk

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00235287

Study ID Number: RAS-block study

ClinicalTrials.gov Identifier: NCT00235287

Health Authority: Denmark: National Board of Health