Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
Information source: Herlev Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Chronic; Cardiovascular Diseases
Intervention: Candesartan and enalapril (Drug); candesartan and enalapril (Drug); candesartan and enalapril (Drug); candesartan and enalapril (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Herlev Hospital Official(s) and/or principal investigator(s): Marie Frimodt-Møller, MD, Principal Investigator, Affiliation: Dept. of Nephrology, Herlev University Hospital
Overall contact: Marie Frimodt-Møller, MD, Phone: + 45 44 88 44 88, Ext: 84878, Email: marfri01@heh.regionh.dk
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pulse wave velocity (aortic and brachial)
Secondary outcome: augmentation indexblood pressure (brachial and aortic) buckbergs index time to reflection pulse pressure change in glomerular filtration rate (GFR) blood parameters
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Marie Frimodt-Møller, MD, Phone: + 45 44 88 44 88, Ext: 84878, Email: marfri01@heh.regionh.dk
Dept. of Nephrology, Herlev University Hospital, Herlev 2730, Denmark; Recruiting Marie Frimodt-Møller, MD, Phone: + 45 44 88 44 88, Ext: 84878, Email: marfri01@heh.regionh.dk Arne H Nielsen, MD, Prof., Phone: + 45 44 88 44 88, Ext: 82277, Email: arhn@heh.regionh.dk Marie Frimodt-Møller, MD, Principal Investigator
Additional Information
Starting date: September 2005
Last updated: January 16, 2009
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