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Prospective L-arginine Study

This study has been terminated.
(Technical difficulty with Endo-PAT machine)
Sponsor:
Information provided by (Responsible Party):
josh friedland-little, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01485757
First received: November 29, 2011
Last updated: June 11, 2015
Last verified: June 2015
History of Changes
  Purpose
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 Intervention Phase
Heart Transplant
 Drug: L-arginine
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.
Enrollment: 3
Study Start Date: July 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility
Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: josh friedland-little, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01485757     History of Changes
Other Study ID Numbers: HUM00035716 
Study First Received: November 29, 2011
Last Updated: June 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
patients

ClinicalTrials.gov processed this record on September 27, 2016