Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease

This study is currently recruiting participants.

Verified by Herlev Hospital, September 2007

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00235287

Purpose

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.

Condition	Intervention	Phase
Kidney Failure, Chronic Cardiovascular Diseases	Drug: candesartan/Atacand and enalapril	Phase IV

MedlinePlus related topics: Kidney Failure

Drug Information available for: Candesartan cilexetil CV 11974 Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

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

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:

pulse wave velocity (aortic and brachial)

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235287

Contacts

Contact: Marie Frimodt-Møller, MD	+ 45 44 88 44 88 ext 84878	marfri01@heh.regionh.dk
Contact: Arne H Nielsen, MD, Prof.	+ 45 44 88 44 88 ext 82277	arhn@heh.regionh.dk

Locations

Denmark
Dept. of Nephrology, Herlev University Hospital	Recruiting
Herlev, Denmark, 2730
Contact: Marie Frimodt-Møller, MD + 45 44 88 44 88 ext 84878 marfri01@heh.regionh.dk
Contact: Arne H Nielsen, MD, Prof. + 45 44 88 44 88 ext 82277 arhn@heh.regionh.dk
Principal Investigator: Marie Frimodt-Møller, MD

Sponsors and Collaborators

Herlev Hospital

Investigators

Principal Investigator:

Marie Frimodt-Møller, MD

Dept. of Nephrology, Herlev University Hospital

More Information

Study ID Numbers:	RAS-block study
Study First Received:	October 6, 2005
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00235287
Health Authority:	Denmark: National Board of Health

Keywords provided by Herlev Hospital:

Angiotensin-Converting Enzyme Inhibitors
type 1 angiotensin receptor antagonists
blood pressure

Study placed in the following topic categories:

Candesartan cilexetil
Enalapril
Renal Insufficiency
Enalaprilat
Urologic Diseases
Renal Insufficiency, Chronic

Candesartan
Kidney Failure, Chronic
Kidney Diseases
Angiotensin II
Kidney Failure

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009