Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03401476
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2017-04-30
Brief Title:
Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension
Sponsor:
John Granton
Organization:
University Health Network Toronto
Study Overview
Official Title:
Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite advances in treatment and corresponding improvements in survival patients with pulmonary arterial hypertension PAH remain highly symptomatic In one survey of 315 patients with PAH sixty-eight percent had moderate or severe dyspnea on exertion and 40 had a profound and clinically significant deficit in quality of life Palliative care is being increasingly investigated in life-limiting cardiovascular diseases to alleviate symptoms In PAH its implementation is frequently delayed until end-of-life Opioids are a common palliative care intervention however the efficacy and safety of opioids for symptom relief in PAH has not been evaluated
Detailed Description:
There is biologic plausibility for opioids in the treatment of dyspnea in PAH Opioids have widespread effects including venodilation vasodilation reducing sympathetic outflow blunting hypercapnic and hypoxic ventilatory responses and altering the central perception of dyspnea Although the origins of dyspnea in PAH are incompletely understood and multifactorial right ventricular dysfunction reduces exercise capacity and likely also plays a role in the development of dyspnea Mechanoreceptors situated in the right atrium and right ventricle sense elevated pressures and via sympathetic afferents may lead to an augmentation of ventilatory response and hence dyspnea Morphine may specifically antagonize this feedback loop by causing venodilation and blunting sympathetics Morphine also reduces central chemosensitivity and perceptions of dyspnea Therefore the drug may antagonize both peripheral and central drivers of dyspnea in PAH
Investigators will conduct a single-center feasibility study of morphine for treatment of dyspnea and exercise intolerance in PAH Participants will complete two 6-minute walk tests 6MWT within one week Participants will be randomly assigned to receive morphine prior to either the first or second 6MWT Symptoms and 6-minute walk distance 6MWD will be compared between the two tests
Investigators will conduct a single-center feasibility study of morphine for treatment of dyspnea and exercise intolerance in PAH Participants will complete two 6-minute walk tests 6MWT within one week Participants will be randomly assigned to receive morphine prior to either the first or second 6MWT Symptoms and 6-minute walk distance 6MWD will be compared between the two tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None