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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 index

blood 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

Page last updated: August 23, 2015

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