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Completed

NCT Number: NCT01214746

The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

About this study

Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.

On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.

Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron.

Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.

The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women, age 18-40 years
  • Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion criteria

  • Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
  • Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
  • Neoplastic disease
  • Alcohol abuse,
  • Drug abuse
  • Medical treatment except oral anticontraceptive
  • Smoking
  • Pregnancy or
  • Abnormal blood and urine sample
  • Abnormal ECG
  • Blood donation within a month before examination

Treatment and study plan

Placebo

Drug

1 tablet Unikalk 1 time pr day for 5 days

Other names: Unikalk

atorvastatin

Drug

Zarator, 80 mg pr day for 5 days

Other names: Zarator

Primary outcomes

  1. Fractional excretion of sodium

    Time frame: 5 days treatment

    Sodium excretion measured before, during and after L-NMMA infusion

Secondary outcomes

  1. Systolic blood pressure (SBP)

    Time frame: 5 days

  2. Pulse wave velocity

    Time frame: 5 days

  3. plasma renin concentration

    Time frame: 5 days

  4. Augmentation index (AI)

    Time frame: 5 days

  5. Diastolic blood pressure

    Time frame: 5 days

  6. Plasma aldosterone concentration

    Time frame: 5 days

  7. Plasma and urinary albumin concentration

    Time frame: 5 days

  8. Urinary excretion of aquaporin-2

    Time frame: 5 days

  9. plasma atrial natriuretic peptide concentration

    Time frame: 5 days

  10. Plasma brain natriuretic peptide concentration

    Time frame: 5 days

  11. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Acronym: STAR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Aug 16, 2011

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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