Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

Phase 4

Completed

• Conditions: Stable Chronic Kidney Disease; Hypertension
• Interventions: Drug: Atorvastatin

• Registration Number: NCT01257009
• Lead Sponsor: 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.

Detailed Description

see above

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-11
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Last Update Submitted: 2010-12-08
• Study First Posted: 2010-12-09
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• stable chronic kidney disease
• Hypertension

Exclusion Criteria

• renal replacement therapy
• pregnancy
• diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Atorvastatin	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.
2	Atorvastatin	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

Primary Outcome Measures

Name	Time	Method
Sympathetic activity	4-6 weeks treatment

Trial Locations

Locations (1)

University Medical Center utrecht; 🇳🇱 Utrecht, Netherlands