L-Arginine Metabolism in Essential Hypertension

• ClinicalTrials.gov Identifier: NCT00137124
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: July 10, 2012
• Sponsor: University of Erlangen-Nürnberg Medical School
• Information provided by (Responsible Party): University of Erlangen-Nürnberg Medical School

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
Essential Hypertension	Drug: L-Arginine	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Intervention Details:

• Drug: L-Arginine
  oral administration of L-arginine for 4 weeks

Outcome Measures

Primary Outcome Measures :

1. meaning of L-arginine transport and metabolism on endothelial function [ Time Frame: 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT00137124
• Other Study ID Numbers: KFO 106 TP8
• First Posted: August 29, 2005
• Last Update Posted: July 10, 2012
• Last Verified: July 2012

Keywords provided by University of Erlangen-Nürnberg Medical School:

Essential hypertension

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases