L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function

This study has been completed.
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
  • exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
  • cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
  • to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients

Condition Intervention Phase
Heart Transplantation
Drug: 12 g of L-arginine glutamate during 6 weeks twice a day
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Maximal and sub maximal exercise capacity at the end of the 6 weeks L-arginine supplementation. Renal function at the end of the 6 weeks

Secondary Outcome Measures:
  • No secondary effects

Estimated Enrollment: 30
Study Start Date: February 2004
Estimated Study Completion Date: December 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male (> 18 years old) stable heart transplant recipient for at least 6 weeks
  • Stable treatment for at least 3 months
  • Sedentary people

Exclusion Criteria:

  • Unstable cardiac pathology
  • Obesity (IMC > 40)
  • Participation in another study in the last month
  • Chronic renal failure (creatinine clearance < 20 ml/min)
  • Renal transplantation
  • Diabetes
  • Impossibility to practice exercise test
  • Nitrate therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213915

Institut de Physiologie
Strasbourg, France, 67091
Service de Chirurgie Vasculaire
Strasbourg, France, 67091
Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Stephane DOUTRELEAU, MD Service de Physiologie et d'Explorations Fonctionnelles
  More Information

ClinicalTrials.gov Identifier: NCT00213915     History of Changes
Other Study ID Numbers: 3031 
Study First Received: September 13, 2005
Last Updated: November 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
exercise capacity
renal function
nitric oxide
exercise capacity using a maximal exercise test
urinary elimination of a saline load using blood and urinary samples

ClinicalTrials.gov processed this record on May 25, 2016