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

Cardiovascular Diseases Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214746
• Other study ID #: EBP-FHC-2010-1
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2010
• Last updated: August 15, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Nephropathy

Intervention

Drug:
• Placebo
1 tablet Unikalk 1 time pr day for 5 days
• Atorvastatin
Zarator, 80 mg pr day for 5 days

Locations

Country	Name	City	State
Denmark	Medicinsk Forskning, Regionshospitalet Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional excretion of sodium	Sodium excretion measured before, during and after L-NMMA infusion	5 days treatment	No
Secondary	Systolic blood pressure (SBP)		5 days	No
Secondary	Pulse wave velocity		5 days	No
Secondary	plasma renin concentration		5 days	No
Secondary	Augmentation index (AI)		5 days	No
Secondary	Diastolic blood pressure		5 days	No
Secondary	Plasma aldosterone concentration		5 days	No
Secondary	Plasma and urinary albumin concentration		5 days	No
Secondary	Urinary excretion of aquaporin-2		5 days	No
Secondary	plasma atrial natriuretic peptide concentration		5 days	No
Secondary	Plasma brain natriuretic peptide concentration		5 days	No
Secondary	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)		5 days	No