Prospective L-arginine Study

Phase 1

Terminated

• Conditions: Heart Transplant
• Interventions: Drug: L-arginine

• Registration Number: NCT01485757
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L-arginine	L-arginine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan Pediatric Heart Transplant Clinic; 🇺🇸 Ann Arbor, Michigan, United States