Prospective L-arginine Study

Sponsor

University of Michigan (Other)

Overall Status

Terminated

CT.gov ID

NCT01485757

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Transplant	Drug: L-arginine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Pediatric Heart Transplant Clinic	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Josh Friedland-Little, MD, Principal Investigator, University of Michigan

ClinicalTrials.gov Identifier:

NCT01485757

Other Study ID Numbers:

HUM00035716

First Posted:

Dec 5, 2011

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Keywords provided by Josh Friedland-Little, MD, Principal Investigator, University of Michigan

patients

Study Results

No Results Posted as of Jan 10, 2017