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Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01257009
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
Sponsor:
Information provided by:
UMC Utrecht

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.


Condition or disease Intervention/treatment Phase
Stable Chronic Kidney Disease Hypertension Drug: Atorvastatin Phase 4

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease
Study Start Date : August 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
1
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.
Drug: Atorvastatin
6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
Other Name: Lipitor
2
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
Drug: Atorvastatin
6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
Other Name: Lipitor



Primary Outcome Measures :
  1. Sympathetic activity [ Time Frame: 4-6 weeks treatment ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable chronic kidney disease
  • Hypertension

Exclusion Criteria:

  • renal replacement therapy
  • pregnancy
  • diabetes mellitus

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): NCT01257009


Locations
Netherlands
University Medical Center utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht

ClinicalTrials.gov Identifier: NCT01257009     History of Changes
Other Study ID Numbers: Statin sympathetic
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: November 2010

Keywords provided by UMC Utrecht:
sympathetic activity
chronic kidney disease
atorvastatin
lipitor

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors