L-Arginine Metabolism in Essential Hypertension
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- meaning of L-arginine transport and metabolism on endothelial function [4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males, ages 18-65
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Male and female healthy control subjects ages 18-65
Exclusion Criteria:
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Any other coexisting condition
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Advanced damage of vital organs (grade III und IV retinopathy)
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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)
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Blood donation within the last 4 weeks
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Patients with arterial fibrillation or atrioventricular (AV)-block (II and more)
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Patients with anamnestic myocardial infarct
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Patients with depression
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Patients with seizure disorders
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Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV
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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.
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Actual or anamnestic alcohol or drug abuse
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History of organ transplant
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Anaphylaxis or known therapy resistance to any of the used test matters.
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Therapy with a not approved concomitant therapy
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Participation in another study within three months prior to study inclusion
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Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance
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Liver or kidney diseases: SGOT, GPT , γ-GT, AP, bilirubin and creatinine above 200% of standard
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Patients who are not sufficiently compliant; or patients who are not capable or willing to appear for controlling visits.
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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
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Presumed risk of transmission of HIV or hepatitis via blood from the proband
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg | Erlangen | Germany | 91054 |
Sponsors and Collaborators
- University of Erlangen-Nürnberg Medical School
Investigators
- Principal Investigator: Markus P Schlaich, MD, CRC, Medizinische Klinik 4 - Nephrology and Hypertension
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KFO 106 TP8