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Prospective L-arginine Study
This study has been terminated.
(Technical difficulty with Endo-PAT machine)
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Josh Friedland-Little, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01485757
First received: November 29, 2011
Last updated: January 9, 2017
Last verified: January 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Heart Transplant | Drug: L-arginine | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by Josh Friedland-Little, MD, University of Michigan:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 3 |
| Study Start Date: | July 2011 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
Eligibility| Ages Eligible for Study: | 8 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01485757
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485757
Locations
| United States, Michigan | |
| University of Michigan Pediatric Heart Transplant Clinic | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan
More Information
| Responsible Party: | Josh Friedland-Little, MD, Principal Investigator, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01485757 History of Changes |
| Other Study ID Numbers: |
HUM00035716 |
| Study First Received: | November 29, 2011 |
| Last Updated: | January 9, 2017 |
Keywords provided by Josh Friedland-Little, MD, University of Michigan:
|
patients |
ClinicalTrials.gov processed this record on September 21, 2017