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 — DRUGArginine Hydrochloride 60% concentration injection 15 g in 25 mL, contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.
- Placebo — OTHERSaline
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-arginineIntravenous infusion of L-arginine (250-350 mg/kg) will be performed for 30 minutes.
- Placebo Comparator: SalineSaline 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
- Paul J Fadel, PhD8172724653
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19716 | David Edwards, PhD |
| UT Southwestern | Dallas | Texas | 75390 |
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