L-Arginine Metabolism in Essential Hypertension

This study has been completed.
Sponsor:
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
  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 April 16, 2014