L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03982160|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: L-Arginine Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This will be a randomize, saline-controlled crossover design study|
|Masking Description:||Subjects will receive systemic intravenous infusion of L-arginine or saline for 30 minutes in a randomized order. The randomization will be carried out by research personnel.|
|Primary Purpose:||Basic Science|
|Official Title:||Role of Decreased Nitric Oxide in the Tonic Elevation of Resting Sympathetic Nerve Activity in Chronic Kidney Disease Patients|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982160
|Contact: Paul J Fadel, PhD||8172724653||Paul.Fadel@uta.edu|
|United States, Delaware|
|University of Delaware||Recruiting|
|Newark, Delaware, United States, 19716|
|Contact: David Edwards, PhD email@example.com|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Contact: Robert Toto, MD 214-648-2600 firstname.lastname@example.org|
|Principal Investigator:||Paul J Fadel, PhD||University of Texas at Arlington|