Prospective L-arginine Study

Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01485757

Enrollment

Registered

2011-12-05

Start date

2011-07-31

Completion date

2015-07-31

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant

Keywords

patients

Brief summary

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.

Interventions

DRUGL-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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine.	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

Measure	Time frame	Description
Change from baseline in serum levels of oxidative stress markers	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	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026