The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake

Phase 4

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00678184
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

Detailed Description

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-05
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Last Update Submitted: 2008-05-14
• Study First Posted: 2008-05-15
• Last Update Posted: 2008-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Age 20-50 yr
2. BMI<30
3. Females had to use oral contraceptive treatment or IUD.

Exclusion Criteria

1. Clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or endocrine organs
2. Abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine, blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase)
3. Albuminuria or glucosuria
4. cancer
5. arterial hypertension
6. alcohol abuse
7. medical treatment, except contraceptives
8. pregnancy or breast feeding
9. blood donation one month before the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance	6 months

Secondary Outcome Measures

Name	Time	Method
AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR.	6 months

Trial Locations

Locations (2)

Medical Research; 🇩🇰 Holstebro, Denmark

Department of Medical Research, Holstebro Hospital; 🇩🇰 Holstebro, Denmark