L-Arginine Metabolism in Essential Hypertension

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Criteria

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