NCT02164318

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

Terminated NA Results posted Last updated 12 July 2017

What this trial tests

NA trial testing Handgrip training in End Stage Renal Disease in 11 participants. Terminated before completion.

Timeline

1 September 2014

Primary endpoint
18 February 2016

10 March 2017

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	11
Start date	1 September 2014
Primary completion	18 February 2016
Estimated completion	10 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Handgrip training
• Nitroglycerin ointment

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Duke University

Who can join

12 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Participants With Mature Arteriovenous Fistula (AVF) Primary · 3 month post surgery to create AVF

Use of AVF for dialysis for dialysis dependent participants, or fistula deemed mature based on physical exam in predialysis participants (diameter \>6 mm, blood flow \>600 ml by ultrasound or estimated by physical exam).

Group	Value	95% CI
Control Group	2
Handgrip Training Group	0
Nitroglycerin Ointment Group	1
Combined Handgrip Training /Nitroglycerin Ointment Group	0
Control Group	0
Handgrip Training Group	0
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	1
Control Group	0
Handgrip Training Group	1
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	1
Control Group	2
Handgrip Training Group	1
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	0

Count of Participants With a Patent Fistula Secondary · 3 months post surgery

Determination that AVF is patent (has blood flow, no occlusion).

Group	Value	95% CI
Control Group	4
Handgrip Training Group	2
Nitroglycerin Ointment Group	1
Combined Handgrip Training /Nitroglycerin Ointment Group	2
Control Group	0
Handgrip Training Group	0
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	0

Count of Participants Using Their AVF for Dialysis Secondary · 12 months post surgery

Successful use of AVF at 12 months in dialysis dependent patients. Not relevant in participants that are predialysis or that discontinue dialysis prior to AVF use.

Group	Value	95% CI
Control Group	2
Handgrip Training Group	2
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	1
Control Group	0
Handgrip Training Group	0
Nitroglycerin Ointment Group	0
Combined Handgrip Training /Nitroglycerin Ointment Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented.". Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group

Serious: 0/4 (0%)

Deaths: —

Handgrip Training Group

Serious: 0/3 (0%)

Deaths: —

Nitroglycerin Ointment Group

Serious: 0/1 (0%)

Deaths: —

Combined Handgrip Training /Nitroglycerin Ointment Group

Serious: 2/3 (67%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Control Group	Handgrip Training Group	Nitroglycerin Ointment Group	Combined Handgrip Training…
Acute uremia/dialysis initiation	Renal and urinary disorders	—	—	—	—
Stroke/Cerebrovascular Accident	Nervous system disorders	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Control Group	Handgrip Training Group	Nitroglycerin Ointment Group	Combined Handgrip Training…
Head/arm/shoulder pain/discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hypertension/Bradycardia/Chest Pain	Cardiac disorders	—	—	—	—
Dizziness/Nausea	Nervous system disorders	—	—	—	—
Vomitting	Nervous system disorders	—	—	—	—
Hyperkalemia	Renal and urinary disorders	—	—	—	—

Most-reported serious reactions: Acute uremia/dialysis initiation, Stroke/Cerebrovascular Accident.

Data from ClinicalTrials.gov NCT02164318 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. New Insights into Dialysis Vascular Access: Molecular Targets in Arteriovenous Fistula and Arteriovenous Graft Failure and Their Potential to Improve Vascular Access Outcomes.
   Lee T, Misra S. · · 2016 · cited 52× · PMID 27401527 · DOI 10.2215/cjn.02030216
2. Cellular and molecular mechanisms underlying hemodialysis arteriovenous fistula dysfunction and approaches to promote maturation: a vascular perspective.
   Shiu YT, Northrup H, Huang Y, Cho ME, et al · · 2025 · cited 7× · PMID 40465509 · DOI 10.1152/ajpheart.00010.2025