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

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ClinicalTrials.gov Identifier: NCT01214746
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : August 16, 2011
Sponsor:
Information provided by:
Regional Hospital Holstebro

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Nephropathy Drug: Placebo Drug: Atorvastatin Phase 2

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
1 tablet Unikalk 1 time pr day for 5 days
Other Name: Unikalk

Active Comparator: Atorvastatin Drug: Atorvastatin
Zarator, 80 mg pr day for 5 days
Other Name: Zarator




Primary Outcome Measures :
  1. Fractional excretion of sodium [ Time Frame: 5 days treatment ]
    Sodium excretion measured before, during and after L-NMMA infusion


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214746


Locations
Denmark
Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Frank H Christensen, MD Medicinsk Forskning

Responsible Party: MD Frank Holden Christensen, Department of Medical Research, Regionshospitalet Holstebro
ClinicalTrials.gov Identifier: NCT01214746     History of Changes
Other Study ID Numbers: EBP-FHC-2010-1
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Regional Hospital Holstebro:
Statin
L-NMMA
Healthy subjects
Nephrology

Additional relevant MeSH terms:
Cardiovascular Diseases
Atorvastatin Calcium
Nitric Oxide
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents