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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Herlev Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235287
First Posted: October 10, 2005
Last Update Posted: January 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herlev Hospital
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • augmentation index [ Time Frame: 0, 8, 16 and 24 weeks after start of intervention ]
  • blood pressure (brachial and aortic) [ Time Frame: 0, 8, 16 and 24 weeks after start of intervention ]
  • buckbergs index [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ]
  • time to reflection [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ]
  • pulse pressure [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ]
  • change in glomerular filtration rate (GFR) [ Time Frame: 0, 8, 16 and 24 weeks after start of interven ]
  • blood parameters [ Time Frame: at start of intervention and after each 2.5 - 3.week in the study period ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: January 19, 2009
Last Verified: January 2009

Keywords provided by Herlev Hospital:
Angiotensin-Converting Enzyme Inhibitors
type 1 angiotensin receptor antagonists
blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Candesartan
Candesartan cilexetil
Enalapril
Enalaprilat
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors