L-Arginine Metabolism in Essential Hypertension

Overview

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.

Full Title of Study: “Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2009

Interventions

  • Drug: L-Arginine
    • oral administration of L-arginine for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • meaning of L-arginine transport and metabolism on endothelial function
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Erlangen-Nürnberg Medical School
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Markus P Schlaich, MD, Principal Investigator, CRC, Medizinische Klinik 4 – Nephrology and Hypertension

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