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

NCT ID: NCT00213915

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-12-31

Brief Summary

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* 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

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Conditions

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Heart Transplantation

Keywords

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephane DOUTRELEAU, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Physiologie et d'Explorations Fonctionnelles

Locations

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Institut de Physiologie

Strasbourg, , France

Site Status

Service de Chirurgie Vasculaire

Strasbourg, , France

Site Status

Service des Explorations Fonctionnelles Respiratoires et de l'Exercice

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 20200265 (View on PubMed)

Other Identifiers

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3031

Identifier Type: -

Identifier Source: org_study_id