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

September 13, 2005
November 28, 2007
February 2004
Not Provided
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
Same as current
Complete list of historical versions of study NCT00213915 on ClinicalTrials.gov Archive Site
No secondary effects
Same as current
Not Provided
Not Provided
 
L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function
Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Heart Transplantation
Drug: 12 g of L-arginine glutamate during 6 weeks twice a day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00213915
3031
Not Provided
Not Provided
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Stephane DOUTRELEAU, MD Service de Physiologie et d'Explorations Fonctionnelles
University Hospital, Strasbourg, France
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP