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

Sponsor:	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 and enalapril Drug: candesartan and enalapril	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

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

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:

pulse wave velocity (aortic and brachial) [ Time Frame: 0, 8, 16 and 24 weeks after start of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

augmentation index [ Time Frame: 0, 8, 16 and 24 weeks after start of intervention ] [ Designated as safety issue: No ]
blood pressure (brachial and aortic) [ Time Frame: 0, 8, 16 and 24 weeks after start of intervention ] [ Designated as safety issue: No ]
buckbergs index [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ] [ Designated as safety issue: No ]
time to reflection [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ] [ Designated as safety issue: No ]
pulse pressure [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ] [ Designated as safety issue: No ]
change in glomerular filtration rate (GFR) [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ] [ Designated as safety issue: No ]
blood parameters [ Time Frame: at start of intervention and after each 2.5 - 3.week in the study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2005

Arms	Assigned Interventions
Active Comparator: A,AIIA 24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.	Drug: Candesartan and enalapril 24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.
Active Comparator: A, ACE-I 24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.	Drug: candesartan and enalapril 24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.
Active Comparator: C, AIIA 8 weeks of treatment with Candesartan, followed by 8 weeks of treatment with Enalapril. The treatment in the last 8 out of the 24 weeks is a combination of Candesartan and Enalapril.	Drug: candesartan and enalapril 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg.
Active Comparator: C, ACE 8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg) , followed by 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg) . The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)	Drug: candesartan and enalapril 8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)

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

No publications provided

Responsible Party:	Marie Frimodt-Møller, MD, Dept. of Nephrology, Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00235287 History of Changes
Other Study ID Numbers:	RAS-block study
Study First Received:	October 6, 2005
Last Updated:	January 16, 2009
Health Authority:	Denmark: National Board of Health

Keywords provided by Herlev Hospital:

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

Additional relevant MeSH terms:

Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enalapril
Enalaprilat
Candesartan

Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012