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CompletedNCT00213915Updated Dec 22, 2025

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

A Phase 4 interventional study of 12 g of L-arginine glutamate during 6 weeks twice a day in Heart Transplantation, sponsored by University Hospital, Strasbourg, France. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Strasbourg, France · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Feb 2004, registered Sep 2005).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Heart Transplantation

Keywords

  • 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
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants

Interventions

  • Drug12 g of L-arginine glutamate during 6 weeks twice a day
06

What researchers measure

Primary outcomes

  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 outcomes

  1. No secondary effects

07

Study locations

3 sites
  • Institut de Physiologie
    Strasbourg, 67091, France
  • Service de Chirurgie Vasculaire
    Strasbourg, 67091, France
  • Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
    Strasbourg, 67091, France
08

References and documents

Publications

  • Doutreleau S, Rouyer O, Di Marco P, Lonsdorfer E, Richard R, Piquard F, Geny B. L-arginine supplementation improves exercise capacity after a heart transplant. Am J Clin Nutr. 2010 May;91(5):1261-7. doi: 10.3945/ajcn.2009.27881. Epub 2010 Mar 3. PubMed 20200265 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00213915
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Feb 2004
Completion
Dec 2004
Last update
Dec 22, 2025

Study contacts

Stephane DOUTRELEAU, MD
principal investigator · Service de Physiologie et d'Explorations Fonctionnelles
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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