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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213915
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 29, 2007
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Heart Transplantation Drug: 12 g of L-arginine glutamate during 6 weeks twice a day Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients
Study Start Date : February 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. No secondary effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00213915     History of Changes
Other Study ID Numbers: 3031
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

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