Prospective L-arginine Study

Heart Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01485757
• Other study ID #: HUM00035716
• Status: Terminated
• Phase: Phase 1
• First received: November 29, 2011
• Last updated: January 9, 2017
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplant

Intervention

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).

Locations

Country	Name	City	State
United States	University of Michigan Pediatric Heart Transplant Clinic	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No