Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
Primary Purpose
Stable Chronic Kidney Disease, Hypertension
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Stable Chronic Kidney Disease focused on measuring sympathetic activity, chronic kidney disease, atorvastatin, lipitor
Eligibility Criteria
Inclusion Criteria:
- stable chronic kidney disease
- Hypertension
Exclusion Criteria:
- renal replacement therapy
- pregnancy
- diabetes mellitus
Sites / Locations
- University Medical Center utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Arm 1: cessation of any statin therapy for at least 6 weeks, then the first sympathetic activity measurement will be done.Subsequently, atorvastatin 20mg is added for 6 weeks. Then the second sympathetic measurement will be performed.
Patients will receive atorvastatin for 6 weeks, then the first sympathetic measurement will be done. Then atorvastatin will be stopped and 6 weeks the second measurement will be done
Outcomes
Primary Outcome Measures
Sympathetic activity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01257009
Brief Title
Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
Official Title
Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity.
The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients.
Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added.
Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.
Detailed Description
see above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Chronic Kidney Disease, Hypertension
Keywords
sympathetic activity, chronic kidney disease, atorvastatin, lipitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Arm 1: cessation of any statin therapy for at least 6 weeks, then the first sympathetic activity measurement will be done.Subsequently, atorvastatin 20mg is added for 6 weeks. Then the second sympathetic measurement will be performed.
Arm Title
2
Arm Type
Other
Arm Description
Patients will receive atorvastatin for 6 weeks, then the first sympathetic measurement will be done. Then atorvastatin will be stopped and 6 weeks the second measurement will be done
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
Primary Outcome Measure Information:
Title
Sympathetic activity
Time Frame
4-6 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable chronic kidney disease
Hypertension
Exclusion Criteria:
renal replacement therapy
pregnancy
diabetes mellitus
Facility Information:
Facility Name
University Medical Center utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
12. IPD Sharing Statement
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Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
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