Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05635851 |
| Other study ID # |
H22-00878 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Simon Fraser University |
| Contact |
Victoria Claydon, Dr. |
| Phone |
778-782-8513 |
| Email |
victoria_claydon[@]sfu.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This project aims to evaluate the safety and efficacy of using a short-acting drug to reduce
the maximal blood pressure during dangerous blood pressure spikes that happen during bowel
care in individuals with spinal cord injury. the investigators will monitor the physiological
effects of this drug during at-home bowel care to best understand the drug's effects in
typical use.
Description:
Purpose: The primary purpose of this study is to investigate the effects of sublingual nitric
oxide (NO) donor spray on cardiovascular changes triggered by bowel care.
Hypothesis: NO donor spray will lower the maximum blood pressure spikes during high blood
pressure events triggered by bowel care in people with spinal cord injury.
Justification: In people with spinal cord injury, episodes of high blood pressure are common
during strong sensory stimuli such as those present during routine bowel care. These episodes
of high blood pressure can be dangerous due to the magnitude of blood pressure increase and
because they can be accompanied by irregular heart beats. This condition, known as autonomic
dysreflexia (AD), is most common in individuals with high-level injuries.
The experience of autonomic dysreflexia can vary widely between individuals: some have
goosebumps, sweating, facial flushing or headaches, while others have no symptoms at all,
despite their changes in heart rate and blood pressure.
One possible approach to help manage AD is the use of fast-acting, short-term vasodilators
such as nitric oxide (NO) donors (e.g. glyceryl trinitrate, GTN) to decrease blood pressure
during AD experienced during bowel care. This approach is already part of the clinical
recommendations for management of AD during bowel care, and yet its safety and efficacy have
never been tested during at-home bowel care. Currently, a sublingual GTN spray is not often
used in the home setting, although it is thought that using this medication might reduce the
cardiovascular effects of bowel care after spinal cord injury. The long-term consequences of
these short-term elevations in blood pressure during autonomic dysreflexia are not fully
understood, but given that they are often associated with discomfort, and have been known to
be associated with more severe events such as stroke, it would be beneficial to reduce their
occurrence during daily care routines.
Objectives: The investigators aim to evaluate whether GTN improves AD during normal at-home
bowel care.
Research Design: The study is a randomised placebo-controlled double-blind crossover clinical
trial to evaluate the effect of sublingual GTN (spray) on beat-to-beat cardiovascular
responses to normal bowel care in 26 individuals with chronic high-level SCI who are known to
have AD.
Statistical Analysis: Data will be analysed using R statistical software. Mean maximum blood
pressure and mean drop in systolic blood pressure will be calculated. Mean time to onset of
drug action will also be calculated. A paired t-test will be used to determine if there is a
significant within-participant difference in the change of mean maximum blood pressure values
or mean drop in systolic blood pressure between the placebo and the GTN conditions. Two-way
repeated measures ANOVA will be used to compare symptoms, test conditions, and test phases.
Categorical data will be analysed with Spearman's rank correlations and linear regressions to
determine if any findings correlate with biological variables including level of injury, sex,
and cardiovascular variables.
