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.

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.

Study Overview

• Status: Terminated
• Conditions: Heart Transplant
• Intervention / Treatment: Drug: L-arginine

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Pediatric Heart Transplant Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (ESTIMATE): December 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: patients
• Other Study ID Numbers: HUM00035716