RecruitingPhase 4NCT03982160

L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients

Role of Decreased Nitric Oxide in the Tonic Elevation of Resting Sympathetic Nerve Activity in Chronic Kidney Disease Patients


Sponsor

The University of Texas at Arlington

Enrollment

15 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 35 YearsMax Age: 75 Years

Inclusion Criteria2

  • CKD patients classified as Stage 3 and 4 of National Kidney Foundation Classification with estimated glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine, age, gender, and race.
  • Men and women 35 to 75 years of age

Exclusion Criteria13

  • myocardial infarction
  • heart failure
  • anemia (hemoglobin \<8 g/dl)
  • cancer with current treatment
  • previous organ transplantation
  • immunosuppressant therapy
  • human immunodeficiency virus infection
  • pregnancy and/or lactating
  • current tobacco use
  • taking menopausal drugs (estradiol)
  • treatment for diabetic neuropathy
  • resting heart rate ≥ 100 bpm and
  • systolic blood pressure ≤ 90 mmHg

Interventions

DRUGL-Arginine

Arginine Hydrochloride 60% concentration injection 15 g in 25 mL, contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.

OTHERPlacebo

Saline


Locations(2)

University of Delaware

Newark, Delaware, United States

UT Southwestern

Dallas, Texas, United States

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NCT03982160


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