L-Arginine Metabolism in Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137124
• Other study ID #: KFO 106 TP8
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 26, 2005
• Last updated: July 6, 2012
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: July 2012
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 , ?-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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Germany	CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meaning of L-arginine transport and metabolism on endothelial function		4 weeks	No