Prospective L-arginine Study
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ClinicalTrials.gov Identifier: NCT01485757 |
Recruitment Status
:
Terminated
(Technical difficulty with Endo-PAT machine)
First Posted
: December 5, 2011
Last Update Posted
: January 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Transplant | Drug: L-arginine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients. |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: L-arginine |
Drug: L-arginine
All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).
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- Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. [ Time Frame: baseline and 12 weeks ]Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period.
- Change from baseline in serum levels of oxidative stress markers [ Time Frame: baseline and 12 weeks ]Serum markers of oxidative stress will be measured at baseline and after a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.
- Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine [ Time Frame: baseline and 12 weeks ]Exercise tolerance will be assessed with a 6 minute walk at baseline and following a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.

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Ages Eligible for Study: | 8 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- University of Michigan Pediatric Heart Transplant Clinic patient.
- Greater than or equal to 8 years of age.
- Heart transplant between 1 and 8 years prior to enrollment in the study
Exclusion Criteria:
- Relative hypotension for age
- Refusal to participate
- Inability to cooperate with Endo-PAT testing
- Pregnant or nursing women.
- Insulin dependent diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485757
United States, Michigan | |
University of Michigan Pediatric Heart Transplant Clinic | |
Ann Arbor, Michigan, United States, 48109 |
Responsible Party: | Josh Friedland-Little, MD, Principal Investigator, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01485757 History of Changes |
Other Study ID Numbers: |
HUM00035716 |
First Posted: | December 5, 2011 Key Record Dates |
Last Update Posted: | January 10, 2017 |
Last Verified: | January 2017 |
Keywords provided by Josh Friedland-Little, MD, University of Michigan:
patients |