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HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-arginine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. | 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. | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum levels of oxidative stress markers | 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. | baseline and 12 weeks |
| Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Pediatric Heart Transplant Clinic | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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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. |
| baseline and 12 weeks |
| D000601 | Amino Acids, Essential |