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 because the information has not been verified recently.
Verified January 2009 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00235287
First received: October 6, 2005
Last updated: January 16, 2009
Last verified: January 2009
  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
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Herlev Hospital

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

ClinicalTrials.gov processed this record on September 18, 2014