- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213915
L-arginine Supplementation and Exercise; L-arginine Supplementation and Renal Function
December 15, 2025 updated by: University Hospital, Strasbourg, France
Effects of Oral Chronic L-arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients
- 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Institut de Physiologie
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Strasbourg, France, 67091
- Service de Chirurgie Vasculaire
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Strasbourg, France, 67091
- Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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No secondary effects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephane DOUTRELEAU, MD, Service de Physiologie et d'Explorations Fonctionnelles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimated)
September 21, 2005
Study Record Updates
Last Update Posted (Estimated)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.