Back to resultsPulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
Primary Purpose
Kidney Failure, Chronic, Cardiovascular Diseases
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Candesartan and enalapril
candesartan and enalapril
candesartan and enalapril
candesartan and enalapril
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Angiotensin-Converting Enzyme Inhibitors, type 1 angiotensin receptor antagonists, blood pressure
Eligibility 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
Sites / Locations
- Dept. of Nephrology, Herlev University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
A,AIIA
A, ACE-I
C, AIIA
C, ACE
Arm Description
24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.
24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.
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.
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)
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00235287
Brief Title
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Cardiovascular Diseases
Keywords
Angiotensin-Converting Enzyme Inhibitors, type 1 angiotensin receptor antagonists, blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A,AIIA
Arm Type
Active Comparator
Arm Description
24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.
Arm Title
A, ACE-I
Arm Type
Active Comparator
Arm Description
24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.
Arm Title
C, AIIA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
C, ACE
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Candesartan and enalapril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
candesartan and enalapril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
candesartan and enalapril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
candesartan and enalapril
Intervention Description
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)
Primary Outcome Measure Information:
Title
pulse wave velocity (aortic and brachial)
Time Frame
0, 8, 16 and 24 weeks after start of intervention
Secondary Outcome Measure Information:
Title
augmentation index
Time Frame
0, 8, 16 and 24 weeks after start of intervention
Title
blood pressure (brachial and aortic)
Time Frame
0, 8, 16 and 24 weeks after start of intervention
Title
buckbergs index
Time Frame
0, 8, 16 and 24 weeks after start of interven
Title
time to reflection
Time Frame
0, 8, 16 and 24 weeks after start of interven
Title
pulse pressure
Time Frame
0, 8, 16 and 24 weeks after start of interven
Title
change in glomerular filtration rate (GFR)
Time Frame
0, 8, 16 and 24 weeks after start of interven
Title
blood parameters
Time Frame
at start of intervention and after each 2.5 - 3.week in the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Frimodt-Møller, MD
Phone
+ 45 44 88 44 88
Ext
84878
Email
marfri01@heh.regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Arne H Nielsen, MD, Prof.
Phone
+ 45 44 88 44 88
Ext
82277
Email
arhn@heh.regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Frimodt-Møller, MD
Organizational Affiliation
Dept. of Nephrology, Herlev University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Nephrology, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Frimodt-Møller, MD
Phone
+ 45 44 88 44 88
Ext
84878
Email
marfri01@heh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Arne H Nielsen, MD, Prof.
Phone
+ 45 44 88 44 88
Ext
82277
Email
arhn@heh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Marie Frimodt-Møller, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22860014
Citation
Frimodt-Moller M, Kamper AL, Strandgaard S, Kreiner S, Nielsen AH. Beneficial effects on arterial stiffness and pulse-wave reflection of combined enalapril and candesartan in chronic kidney disease--a randomized trial. PLoS One. 2012;7(7):e41757. doi: 10.1371/journal.pone.0041757. Epub 2012 Jul 31.
Results Reference
derived
Learn more about this trial
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
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