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

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

ChemIDplus related topics:

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
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 October 17, 2008