Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01257009
First received: December 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention Phase
Stable Chronic Kidney Disease
Hypertension
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Sympathetic activity [ Time Frame: 4-6 weeks treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable chronic kidney disease
  • Hypertension

Exclusion Criteria:

  • renal replacement therapy
  • pregnancy
  • diabetes mellitus
  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: NCT01257009

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

No publications provided

ClinicalTrials.gov Identifier: NCT01257009     History of Changes
Other Study ID Numbers: Statin sympathetic
Study First Received: December 8, 2010
Last Updated: December 8, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014