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

NCT ID: NCT02164318

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2017-03-10

Brief 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.

Detailed 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.

Following entry into the study, approximately 4 weeks prior to surgery subjects will undergo a series of non-invasive tests of vascular function in the arm of fistula creation. Following this vascular function testing, subjects will follow the intervention treatment for 4 weeks. After 4 weeks of intervention treatment and prior to surgery, the vascular function analysis will be repeated to determine if the interventions had an effect on arm vascular function. Surgery to create the AVF will follow the second vascular function analysis. A discard sample of the vein used to create the AVF and a blood sample will be collected during surgery to assess potential biologic differences between intervention groups. The interventions will be continued until 4 weeks following surgery. Subjects will be followed to determine if the AVF matured and was successfully used for dialysis.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Handgrip training group

Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes

Group Type: EXPERIMENTAL

Handgrip training

Intervention Type: OTHER

Nitroglycerin ointment group

Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly

Group Type: EXPERIMENTAL

Nitroglycerin ointment

Intervention Type: DRUG

Combined handgrip training /Nitroglycerin ointment group

Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly

Group Type: EXPERIMENTAL

Handgrip training

Intervention Type: OTHER

Nitroglycerin ointment

Intervention Type: DRUG

Interventions

Handgrip training

Intervention Type: OTHER

Nitroglycerin ointment

Intervention Type: DRUG

Other Intervention Names

Nitropaste

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey H Lawson, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

R21DK103082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00054388

Identifier Type: -

Identifier Source: org_study_id