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

This study has been completed.

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00213915

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 IV

Drug Information available for: Sodium chloride Nitric oxide Arginine Arginine hydrochloride Arginine glutamate Glutamic acid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

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:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Study ID Numbers:	3031
Study First Received:	September 13, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00213915
Health Authority:	France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:

Nitric Oxide

ClinicalTrials.gov processed this record on January 14, 2009