L-Arginine Metabolism in Essential Hypertension

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-arginine

Drug

oral administration of L-arginine for 4 weeks

Primary outcomes

meaning of L-arginine transport and metabolism on endothelial function

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Aug 29, 2005
Registry last updated: Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed