Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

NCT01257009 | Completed Phase 4 DMC

• 1 other identifier: Statin sympathetic
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Chronic Kidney Disease; Hypertension

Keywords

sympathetic activity; chronic kidney disease; atorvastatin; lipitor

Outcome Measures

Primary Outcomes (1)

• Sympathetic activity

  4-6 weeks treatment

Study Arms (2)

1

OTHER

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

2

OTHER

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

Interventions

Atorvastatin DRUG

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

Also known as: Lipitor

1; 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic kidney disease
• Hypertension

You may not qualify if:

• renal replacement therapy
• pregnancy
• diabetes mellitus

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: August 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 9, 2010

Record last verified: 2010-11

Locations

NL (1)