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

NCT02164318 | Terminated Results

• 2 other identifiers: Pro00054388R21DK103082
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Count of Participants With Mature Arteriovenous Fistula (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).

  3 month post surgery to create AVF

Secondary Outcomes (2)

• Count of Participants With a Patent Fistula

  3 months post surgery

• Count of Participants Using Their AVF for Dialysis

  12 months post surgery

Study Arms (4)

Control group

NO INTERVENTION

Standard of care

Handgrip training group

EXPERIMENTAL

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

Other: Handgrip training

Nitroglycerin ointment group

EXPERIMENTAL

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

Drug: Nitroglycerin ointment

Combined handgrip training /Nitroglycerin ointment group

EXPERIMENTAL

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

Other: Handgrip training; Drug: Nitroglycerin ointment

Interventions

Handgrip training OTHER

Combined handgrip training /Nitroglycerin ointment group; Handgrip training group

Nitroglycerin ointment DRUG

Also known as: Nitropaste

Combined handgrip training /Nitroglycerin ointment group; Nitroglycerin ointment group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy of at least 6 months
• Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
• Ability to understand and comply with the requirements of the entire study and communicate with the study team.
• Written informed consent using a document that has been approved by the Duke Human Institutional Review Board.
• 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.

You may not qualify if:

• Patients currently on medication that is contraindicated with nitropaste, including isosorbide nitrate therapy, nitroglycerin, minoxidil, or PDE inhibitors (i.e. Sildenafil).
• Patients with a diastolic blood pressure below 65 or a systolic blood pressure below 90.
• Patients with a history of illicit drug use in the previous 5 years.
• Patients who would require AVF placement before completion of the initial 4 weeks of intervention therapy
• Patients who are otherwise are not suitable for 8 weeks of handgrip training or nitropaste therapy.
• Patients under the 18 of age are not eligible for nitropaste interventions

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There are no tests of hypotheses. Rather, the interest of this study is in the assessment of the ability of this design to recruit, retain and conduct the intervention in this sample of subjects.

Results Point of Contact

• Title: Dr. Jeffrey Lawson
• Organization: Duke University Medical Center

lawso006@mc.duke.edu

919-681-2533

Study Officials

• Jeffrey H Lawson, MD/PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: September 1, 2014
• Primary Completion: February 18, 2016
• Study Completion: March 10, 2017
• Last Updated: July 12, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-06

Locations

US (1)