Trial Outcomes & Findings for Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation (NCT NCT02164318)

Last Updated: 2017-07-12

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

3 month post surgery to create AVF

Results posted on

2017-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Standard of care	Handgrip Training Group Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	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 Handgrip training Nitroglycerin ointment
Overall Study STARTED	4	3	1	3
Overall Study COMPLETED	4	2	1	2
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Standard of care	Handgrip Training Group Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	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 Handgrip training Nitroglycerin ointment
Overall Study Withdrawal by Subject	0	1	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=4 Participants Standard of care	Handgrip Training Group n=3 Participants Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group n=1 Participants Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=3 Participants 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 Handgrip training Nitroglycerin ointment	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Continuous	61.8 years STANDARD_DEVIATION 13.9 • n=5 Participants	51.0 years STANDARD_DEVIATION 28.0 • n=7 Participants	41 years STANDARD_DEVIATION 0 • n=5 Participants	53.7 years STANDARD_DEVIATION 10.1 • n=4 Participants	54.7 years STANDARD_DEVIATION 16.7 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	11 participants n=21 Participants
Dialysis Status	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Body Mass Index	33.1 kg/m^2 STANDARD_DEVIATION 14.7 • n=5 Participants	27.6 kg/m^2 STANDARD_DEVIATION 5.8 • n=7 Participants	33.1 kg/m^2 STANDARD_DEVIATION 0 • n=5 Participants	27.2 kg/m^2 STANDARD_DEVIATION 8.0 • n=4 Participants	30.0 kg/m^2 STANDARD_DEVIATION 9.7 • n=21 Participants
Hypertension Status Hypertension: Yes	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Hypertension Status Hypertension: No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Coronary Artery Disease (CAD) Status CAD: Yes	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Coronary Artery Disease (CAD) Status CAD: No	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Diabetes Mellitus (DM) Status DM: Yes	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Diabetes Mellitus (DM) Status DM: No	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
History of thrombotic disorder (TD) TD: Yes	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
History of thrombotic disorder (TD) TD: No	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Hyperlipidemia Status Hyperlipidemia: Yes	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Hyperlipidemia Status Hyperlipidemia: No	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: 3 month post surgery to create AVF

Population: Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.

Outcome measures

Outcome measures
Measure	Control Group n=4 Participants Standard of care	Handgrip Training Group n=2 Participants Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group n=1 Participants Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=2 Participants 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 Handgrip training Nitroglycerin ointment
Count of Participants With Mature Arteriovenous Fistula (AVF) Not Mature AVF: dialysis dependent	2 Participants	1 Participants	0 Participants	0 Participants
Count of Participants With Mature Arteriovenous Fistula (AVF) Mature AVF: Predialysis	2 Participants	0 Participants	1 Participants	0 Participants
Count of Participants With Mature Arteriovenous Fistula (AVF) Mature AVF: dialysis dependent	0 Participants	0 Participants	0 Participants	1 Participants
Count of Participants With Mature Arteriovenous Fistula (AVF) Not Mature AVF: predialysis	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months post surgery

Population: Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.

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

Outcome measures

Outcome measures
Measure	Control Group n=4 Participants Standard of care	Handgrip Training Group n=2 Participants Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group n=1 Participants Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=2 Participants 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 Handgrip training Nitroglycerin ointment
Count of Participants With a Patent Fistula AVF Patent: Yes	4 Participants	2 Participants	1 Participants	2 Participants
Count of Participants With a Patent Fistula AVF Patent: No	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months post surgery

Population: Only subjects who were on dialysis at 12 months are included in the analysis. Only 5 participants were on dialysis at this time.

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.

Outcome measures

Outcome measures
Measure	Control Group n=2 Participants Standard of care	Handgrip Training Group n=2 Participants Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=1 Participants 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 Handgrip training Nitroglycerin ointment
Count of Participants Using Their AVF for Dialysis AVF used for dialysis: Yes	2 Participants	2 Participants	0 Participants	1 Participants
Count of Participants Using Their AVF for Dialysis AVF used for dialysis: No	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Handgrip Training Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nitroglycerin Ointment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Combined Handgrip Training /Nitroglycerin Ointment Group

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=4 participants at risk Standard of care	Handgrip Training Group n=3 participants at risk Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group n=1 participants at risk Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=3 participants at risk 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 Handgrip training Nitroglycerin ointment
Renal and urinary disorders Acute uremia/dialysis initiation	0.00% 0/4 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Nervous system disorders Stroke/Cerebrovascular Accident	0.00% 0/4 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."

Other adverse events

Other adverse events
Measure	Control Group n=4 participants at risk Standard of care	Handgrip Training Group n=3 participants at risk Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training	Nitroglycerin Ointment Group n=1 participants at risk Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment	Combined Handgrip Training /Nitroglycerin Ointment Group n=3 participants at risk 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 Handgrip training Nitroglycerin ointment
Musculoskeletal and connective tissue disorders Head/arm/shoulder pain/discomfort	100.0% 4/4 • Number of events 11 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	66.7% 2/3 • Number of events 9 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	100.0% 1/1 • Number of events 4 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	66.7% 2/3 • Number of events 10 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Nervous system disorders Headache	75.0% 3/4 • Number of events 3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	100.0% 1/1 • Number of events 2 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 2 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Nervous system disorders Dizziness/Nausea	25.0% 1/4 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 2 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	100.0% 1/1 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	66.7% 2/3 • Number of events 5 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Nervous system disorders Vomitting	0.00% 0/4 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	66.7% 2/3 • Number of events 3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Cardiac disorders Hypertension/Bradycardia/Chest Pain	75.0% 3/4 • Number of events 3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	33.3% 1/3 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Renal and urinary disorders Hyperkalemia	25.0% 1/4 • Number of events 1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/1 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."	0.00% 0/3 • All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."

Additional Information

Dr. Jeffrey Lawson

Duke University Medical Center

Phone: 919-681-2533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place