L-arginine Supplementation and Exercise; L-arginine Suppl... | NCT00213915

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

NCT00213915

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Dec 22, 2025Actual

Enrollment

Phase

Phase 4

Conditions

Heart Transplantation

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004Actual

Primary Completion Date

Not provided

Completion Date

Dec 2004Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 22, 2025Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
12 g of L-arginine glutamate during 6 weeks twice a day	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
No secondary effects

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephane DOUTRELEAU, MD	Service de Physiologie et d'Explorations Fonctionnelles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Physiologie		Strasbourg		67091	France
Service de Chirurgie Vasculaire

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20200265	Result	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.