drugset / Trial / NCT02164318

Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation

NCT02164318

RandomizedParallel-groupOpen-labelOther

Summary

This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both. Goals of this study are (A) to measure if recruited subjects can tolerate the intervention protocols, and determine if dependent variable measures, including surgery outcome, and measurement of physiologic and biologic markers, can be obtained; (B) To measure subject compliance and adherence rates for each of the intervention arms and testing visits; (C) To examine which intervention or combination of interventions demonstrates the strongest preliminary effects in order to estimate power for a pivotal intent to treat trial; and (D) explore group differences in clinical vascular markers and biologic markers in vein tissue.

Timeline

Start
2014-09-01
Primary completion
2016-02-18
Completion
2017-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitroglycerin Unknown 15 mg Topical