- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982160
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Paul J Fadel, PhD
- Phone Number: 8172724653
- Email: Paul.Fadel@uta.edu
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19716
- Recruiting
- University of Delaware
-
Contact:
- David Edwards, PhD
- Email: dge@udel.edu
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern
-
Contact:
- Robert Toto, MD
- Phone Number: 214-648-2600
- Email: robert.toto@utsouthwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: L-arginine
Intravenous infusion of L-arginine (250-350 mg/kg) will be performed for 30 minutes.
|
Arginine Hydrochloride 60% concentration injection 15 g in 25 mL, contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.
|
Placebo Comparator: Saline
Saline will be infused for 30 minutes
|
Saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle sympathetic nerve activity (MSNA) will be reduced after L-arginine infusion
Time Frame: 30 minutes
|
Multiunit postganglionic MSNA will be recorded using standard microneurographic techniques.
Briefly, a unipolar tungsten microelectrode will be inserted into muscle fascicles of the peroneal nerve near the fibular head of the right leg.
Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms (University of Iowa Bioengineering, Iowa City, IA).
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul J Fadel, PhD, University of Texas at Arlington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKD-IRB-2016-0069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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