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

• Status: Terminated
• Trial end date: 2017-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Nitric Oxide; Nitroglycerin

Criteria

Inclusion Criteria:

1. Life expectancy of at least 6 months

2. Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.

3. Ability to understand and comply with the requirements of the entire study and communicate with the study team.

4. Written informed consent using a document that has been approved by the Duke Human Institutional Review Board.

5. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test and be willing to use contraception until completion of 8 weeks of intervention. This will include abstinence, barrier methods, hormones, or intra-uterine device.

Exclusion Criteria:

1. Patients currently on medication that is contraindicated with nitropaste, including isosorbide nitrate therapy, nitroglycerin, minoxidil, or PDE inhibitors (i.e. Sildenafil).

2. Patients with a diastolic blood pressure below 65 or a systolic blood pressure below 90.

3. Patients with a history of illicit drug use in the previous 5 years.

4. Patients who would require AVF placement before completion of the initial 4 weeks of intervention therapy

5. Patients who are otherwise are not suitable for 8 weeks of handgrip training or nitropaste therapy.

6. Patients under the 18 of age are not eligible for nitropaste interventions