ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective L-arginine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01485757
Recruitment Status : Terminated (Technical difficulty with Endo-PAT machine)
First Posted : December 5, 2011
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Josh Friedland-Little, MD, University of Michigan

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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 : July 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. [ Time Frame: 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 :
  1. Change from baseline in serum levels of oxidative stress markers [ Time Frame: 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.

  2. Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine [ Time Frame: 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485757


Locations
United States, Michigan
University of Michigan Pediatric Heart Transplant Clinic
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Josh Friedland-Little, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01485757     History of Changes
Other Study ID Numbers: HUM00035716
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Josh Friedland-Little, MD, University of Michigan:
patients