Prospective L-arginine Study
|ClinicalTrials.gov Identifier: NCT01485757|
Recruitment Status : Terminated (Technical difficulty with Endo-PAT machine)
First Posted : December 5, 2011
Last Update Posted : January 10, 2017
|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)|
|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|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
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).
- 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.
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|