Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

NCT ID: NCT01257009

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

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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

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see above

Conditions

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Stable Chronic Kidney Disease Hypertension

Keywords

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sympathetic activity chronic kidney disease atorvastatin lipitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Atorvastatin

Intervention Type DRUG

6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity

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

Group Type OTHER

Atorvastatin

Intervention Type DRUG

6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity

Interventions

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Atorvastatin

6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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Inclusion Criteria

* stable chronic kidney disease
* Hypertension

Exclusion Criteria

* renal replacement therapy
* pregnancy
* diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Locations

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University Medical Center utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Statin sympathetic

Identifier Type: -

Identifier Source: org_study_id