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NCT01257009 Clinical Trial

Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

Hypertension Clinical Trial

Official title:
Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01257009
Other study ID # Statin sympathetic
Secondary ID
Status Completed
Phase Phase 4
First received December 8, 2010
Last updated December 8, 2010
Start date August 2009
Est. completion date July 2010

Study information
Verified date November 2010
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- stable chronic kidney disease

- Hypertension

Exclusion Criteria:

- renal replacement therapy

- pregnancy

- diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity

Locations
Country Name City State
Netherlands University Medical Center utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sympathetic activity 4-6 weeks treatment Yes
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