Prospective L-arginine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

NCT00856817

Atherosclerotic Cardiovascular Disease

TERMINATED PHASE4

Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects

NCT02675660

Healthy

COMPLETED PHASE1

L-arginine and Brown Adipose Tissue

NCT02291458

Adipose Tissue, Brown Glucose Intolerance Nitric Oxide

UNKNOWN PHASE3

L-citrulline Supplementation, Cold Exposure, & Post-Exercise Muscle Ischemia

NCT02104375

Hypertension

COMPLETED PHASE1/PHASE2

Nutritional Supplements and Nitric Oxide Bioactivity

NCT03625596

Nitric Oxide Vascular Function L-Arginine +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L-arginine

Group Type EXPERIMENTAL

L-arginine

Intervention Type DRUG

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No