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

Regional Hospital Holstebro

Status and phase: Completed; Phase 2

Conditions: Nephropathy; Cardiovascular Diseases

Treatments: Drug: Atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01214746

EBP-FHC-2010-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin