Essential Hypertension
Conditions
Keywords
Essential hypertension
Brief 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.
Interventions
DRUGL-Arginine
oral administration of L-arginine for 4 weeks
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| meaning of L-arginine transport and metabolism on endothelial function | 4 weeks |
Countries
Germany
Outcome results
None listed