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NCT Number: NCT00678184

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

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.

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Key information

Conditions

Healthy Subjects

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medical Research, Holstebro Hospital, Holstebro, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

atorvastatin

Drug

80 mg atorvastatin on two following days each

Primary outcomes

  1. Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance

    Time frame: 6 months

Secondary outcomes

  1. AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

The Effect of Acute HMG-CoA-Reductase Inhibition (Atorvastatin) on Renal Sodium Excretion, Renal Hemodynamics, Tubular Function and Vasoactive Hormones in Healthy Subjects During Normal and High Sodium Intake

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 15, 2008
Registry last updated
May 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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