L-Arginine Metabolism in Essential Hypertension

NCT00137124 | Completed Phase 2

• 1 other identifier: KFO 106 TP8
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

Essential hypertension

Outcome Measures

Primary Outcomes (1)

• meaning of L-arginine transport and metabolism on endothelial function

  4 weeks

Interventions

L-Arginine DRUG

oral administration of L-arginine for 4 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, ages 18-65
• Male and female healthy control subjects ages 18-65

You may not qualify if:

• 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
• Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Arginine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Markus P Schlaich, MD

  CRC, Medizinische Klinik 4 - Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)