L-Arginine Metabolism in Essential Hypertension
This study has been completed.
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00137124
First received: August 26, 2005
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: L-Arginine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- meaning of L-arginine transport and metabolism on endothelial function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: L-Arginine
oral administration of L-arginine for 4 weeks
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137124
Locations
| Germany | |
| 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 |
More Information
No publications provided
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT00137124 History of Changes |
| Other Study ID Numbers: | KFO 106 TP8 |
| Study First Received: | August 26, 2005 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
Essential hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013