L-Arginine Metabolism in Essential Hypertension

Study Overview
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Brief Summary
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Essential hypertension is characterized by impaired endothelial function. Data derived from normotensive subjects with a genetic predisposition to arterial hypertension suggest that endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in the L-arginine/NO pathway can be postulated. The investigators at the University of Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension is associated with alterations in L-arginine metabolism and transport. This study will determine whether metabolism and transport of L-arginine are altered in patients with essential hypertension and whether these potential alterations can be targeted therapeutically.

Official Title
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Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: L-Arginine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, ages 18-65 Male and female healthy control subjects ages 18-65 Exclusion Criteria: Any other coexisting condition Advanced damage of vital organs (grade III und IV retinopathy) Therapy with a not approved concomitant medication in the last 4 weeks prior to intake of the first trial medication, especially lipid lowering and antidiabetic medications (washout phase) Blood donation within the last 4 weeks Patients with arterial fibrillation or atrioventricular (AV)-block (II and more) Patients with anamnestic myocardial infarct Patients with depression Patients with seizure disorders Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV History of a malignant illness with the exception of those patients who have recovered for more than 10 years or have a basalioma of the skin. Actual or anamnestic alcohol or drug abuse History of organ transplant Anaphylaxis or known therapy resistance to any of the used test matters. Therapy with a not approved concomitant therapy Participation in another study within three months prior to study inclusion Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance Liver or kidney diseases: SGOT, GPT , γ-GT, AP, bilirubin and creatinine above 200% of standard Patients who are not sufficiently compliant; or patients who are not capable or willing to appear for controlling visits. Severe or unstable medical or psychiatric illnesses, which will, in the estimation of the examiner, endanger the safety of the proband or the successful participation in the study Presumed risk of transmission of HIV or hepatitis via blood from the proband

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-Arginine|oral administration of L-arginine for 4 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| meaning of L-arginine transport and metabolism on endothelial function |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential hypertension