End Stage Renal DiseaseNCT02164318
Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation
A study testing Handgrip training and Nitroglycerin ointment in people with End Stage Renal Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Handgrip training and Nitroglycerin ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 10 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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.
Read the 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
- Being tested
- Handgrip training, Nitroglycerin ointment
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip trainingOther
Nitroglycerin ointmentDrug
Also called Nitropaste
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Handgrip training |
| Nitroglycerin ointment group | Experimental | Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Receives: 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 Receives: Other: Handgrip training; Drug: Nitroglycerin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 month post surgery to create AVF
Secondary outcomes (2)
Count of Participants With a Patent Fistula
Determination that AVF is patent (has blood flow, no occlusion).
Measured: 3 months post surgery
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.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start1 Sep 2014
- Primary completion18 Feb 2016
- Study completion10 Mar 2017
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey H Lawson, MD/PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164318
- Sponsor's protocol ID
- Pro00054388
- Other IDs
- R21DK103082
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2014
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation
- ClinicalTrials.gov ID
- NCT02164318
- Acronym / sponsor ID
- Pro00054388
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2014
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard of care |
| Handgrip training group | Experimental | Other: Handgrip trainingPerform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes |
| Nitroglycerin ointment group | Experimental | Drug: Nitroglycerin ointmentApply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly |
| Combined handgrip training /Nitroglycerin ointment group | Experimental | Other: Handgrip training, Drug: Nitroglycerin ointmentPerform 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip training | Other | Combined handgrip training /Nitroglycerin ointment group, Handgrip training group |
| Nitroglycerin ointmentAlso: Nitropaste | Drug | Combined handgrip training /Nitroglycerin ointment group, Nitroglycerin ointment group |
Primary outcome
Count of Participants With Mature Arteriovenous Fistula (AVF)
Time frame: 3 month post surgery to create 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).
2 secondary outcomes
Count of Participants With a Patent Fistula
Time frame: 3 months post surgery
Count of Participants Using Their AVF for Dialysis
Time frame: 12 months post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Lawson, MD/PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip training and Nitroglycerin ointment in people with End Stage Renal Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants With Mature Arteriovenous Fistula (AVF) (time frame: 3 month post surgery to create AVF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.