Heart TransplantationPhase 4NCT00213915
L-arginine Supplementation and Exercise; L-arginine Supplementation and Renal Function
A Phase 4 study testing 12 g of L-arginine glutamate during 6 weeks twice a day in people with Heart Transplantation, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- 12 g of L-arginine glutamate during 6 weeks twice a day
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2004to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male (> 18 years old) stable heart transplant recipient for at least 6 weeks
- Stable treatment for at least 3 months
- Sedentary people
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut de Physiologie
Strasbourg, 67091
Service de Chirurgie Vasculaire
Strasbourg, 67091
Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
Strasbourg, 67091
About this study
Official title: 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
- Conditions
- Heart Transplantation
- Being tested
- 12 g of L-arginine glutamate during 6 weeks twice a day
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 g of L-arginine glutamate during 6 weeks twice a dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane DOUTRELEAU, MD, Principal investigator, Service de Physiologie et d'Explorations Fonctionnelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213915
- Sponsor's protocol ID
- 3031
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2005
- Last updated
- 22 Dec 2025
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Chronic L-arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT00213915
- Acronym / sponsor ID
- 3031
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male (> 18 years old) stable heart transplant recipient for at least 6 weeks
- Stable treatment for at least 3 months
- Sedentary people
Key exclusion criteria (8 listed)
- Unstable cardiac pathology
- Obesity (IMC > 40)
- Participation in another study in the last month
- Chronic renal failure (creatinine clearance < 20 ml/min)
- Renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 g of L-arginine glutamate during 6 weeks twice a day | Drug | – |
Primary outcome
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
1 secondary outcome
No secondary effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 20200265Doutreleau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane DOUTRELEAU, MD principal investigator
Service de Physiologie et d'Explorations Fonctionnelles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 12 g of L-arginine glutamate during 6 weeks twice a day in people with Heart Transplantation, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.