Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 10/14/2017 |
| Start Date: | September 1, 2014 |
| End Date: | March 10, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Durham, North Carolina
Principal Investigator: Jeffrey H Lawson, MD/PhD
Phone: 919-681-2533
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