Prospective L-arginine Study

NCT01485757 | Terminated Phase 1 DMC

• 1 other identifier: HUM00035716
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant

Keywords

patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in serum levels of oxidative stress markers

  baseline and 12 weeks

• Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine

  baseline and 12 weeks

Study Arms (1)

L-arginine

EXPERIMENTAL

Drug: L-arginine

Interventions

L-arginine DRUG

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).

L-arginine

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Relative hypotension for age
• Refusal to participate
• Inability to cooperate with Endo-PAT testing
• Pregnant or nursing women.
• Insulin dependent diabetes

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Pediatric Heart Transplant Clinic

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 5, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (1)