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

Primary Purpose

End Stage Renal Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Handgrip training

Nitroglycerin ointment

About this trial

This is an interventional other trial for End Stage Renal Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Control group

Handgrip training group

Nitroglycerin ointment group

Combined handgrip training /Nitroglycerin ointment group

Arm Description

Standard of care

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Count of Participants With a Patent Fistula

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

Count of Participants Using Their AVF for Dialysis

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.

Full Information

NCT ID

NCT02164318

First Posted

June 12, 2014

Last Updated

June 16, 2017

Sponsor

Duke University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02164318

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

September 1, 2014 (undefined)

Primary Completion Date

February 18, 2016 (Actual)

Study Completion Date

March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Standard of care

Arm Title

Handgrip training group

Arm Type

Experimental

Arm Description

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

Arm Title

Nitroglycerin ointment group

Arm Type

Experimental

Arm Description

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

Arm Title

Combined handgrip training /Nitroglycerin ointment group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Handgrip training

Intervention Type

Drug

Intervention Name(s)

Nitroglycerin ointment

Other Intervention Name(s)

Nitropaste

Primary Outcome Measure Information:

Title

Count of Participants With Mature Arteriovenous Fistula (AVF)

Description

Time Frame

3 month post surgery to create AVF

Secondary Outcome Measure Information:

Title

Count of Participants With a Patent Fistula

Description

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

Time Frame

3 months post surgery

Title

Count of Participants Using Their AVF for Dialysis

Description

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.

Time Frame

12 months post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey H Lawson, MD/PhD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

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

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