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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213915
First received: September 13, 2005
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  Purpose
  • 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:

U.S. FDA Resources

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
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213915

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

No publications provided

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:
L-arginine
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 23, 2013