L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients

Part of paid clinical trials in Newark, Delaware.

Sponsor
The University of Texas at Arlington
Study ID
NCT03982160
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • L-Arginine — DRUG
    Arginine Hydrochloride 60% concentration injection 15 g in 25 mL, contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.
  • Placebo — OTHER
    Saline

Study Details

Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. A potential signal driving sympathetic nerve activity (SNA) involves accumulation of the endogenous nitric oxide synthase (NOS) inhibitor asymmetric dimethylarginine (ADMA). ADMA is elevated in CKD and is a strong, independent predictor of future cardiovascular events in these patients. . The goal of this study is to determine whether overcoming the accumulation of endogenous ADMA with acute L-arginine infusion reduces SNA in CKD patients.

Key Dates

Start date
Feb 1, 2018
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: L-arginine
    Intravenous infusion of L-arginine (250-350 mg/kg) will be performed for 30 minutes.
  • Placebo Comparator: Saline
    Saline will be infused for 30 minutes

Primary Outcome Measure

Muscle sympathetic nerve activity (MSNA) will be reduced after L-arginine infusion [ Time Frame: 30 minutes ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of DelawareNewarkDelaware19716
David Edwards, PhD
UT SouthwesternDallasTexas75390
Robert Toto, MD
214-648-2600

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