Prospective L-arginine Study

University of Michigan

Status and phase: Terminated; Phase 1

Conditions: Heart Transplant

Treatments: Drug: L-arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT01485757

HUM00035716

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 8+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

L-arginine

Experimental group

Treatment:

Drug: L-arginine