NCT00213915

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

First QC Date

September 13, 2005

Last Update Submit

December 15, 2025

Conditions

Heart Transplantation

Keywords

L-arginineexercise capacityrenal functionnitric oxideexercise capacity using a maximal exercise testurinary elimination of a saline load using blood and urinary samples

Outcome Measures

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

Interventions

12 g of L-arginine glutamate during 6 weeks twice a dayDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male (\> 18 years old) stable heart transplant recipient for at least 6 weeks
  • Stable treatment for at least 3 months
  • Sedentary people

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut de Physiologie

Strasbourg, 67091, France

Location

Service de Chirurgie Vasculaire

Strasbourg, 67091, France

Location

Service des Explorations Fonctionnelles Respiratoires et de l'Exercice

Strasbourg, 67091, France

Location

Related Publications (1)

  • 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.

    PMID: 20200265RESULT

Study Officials

  • Stephane DOUTRELEAU, MD

    Service de Physiologie et d'Explorations Fonctionnelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2004

Study Completion

December 1, 2004

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(3)