Status:
UNKNOWN
Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension
Lead Sponsor:
John Granton
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-e...
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 ...
Eligibility Criteria
Inclusion
- Aged 18 or older
- Diagnosis of Group 1 pulmonary hypertension including idiopathic PAH, heritable PAH, and PAH that is drug- or toxin-induced, associated with connective tissue disease, human immunodeficiency virus (HIV) infection, congenital heart disease, or schistosomiasis23
- PAH confirmed by means of a right heart catheterization demonstrating:24
- Mean pulmonary arterial pressure of ≥ 25 mmHg
- Pulmonary capillary wedge pressure ≤ 15 mmHg
- Pulmonary vascular resistance of ≥ 3 Wood units
- World Health Organization (WHO) Functional Class III or ambulatory Class IV
- Six-minute walk test performed within the past 6 months demonstrating a distance of at least 50 metres.
- Unchanged PAH medication regimen for 30 days prior to enrolment. Therapy may include endothelin-receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, or oral or parenteral prostacyclin analogues. Diuretic doses may change.
Exclusion
- Group 1 pulmonary hypertension due to portal hypertension
- Group 1 pulmonary hypertension due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
- Groups 2, 3, 4, or 5 pulmonary hypertension
- Severe renal impairment (estimated glomerular filtration rate \< 30 mL/minute/1.73m2 measured within 6 months)
- Severe hepatic impairment (INR \> 2.0 in absence of vitamin K antagonist therapy, serum bilirubin \> 50mmol/L, cirrhosis on imaging or liver biopsy, prior hepatic encephalopathy, or Model for End-Stage Liver Disease (MELD) score \> 19, measured within 6 months, as required based on clinical suspicion)
- Women who are pregnant or breastfeeding (beta-human chorionic gonadotropin (hCG) to confirm non-pregnant status in all females below age 50)
- Hypersensitivity to opioid analgesic, concomitant use with Monoamine Oxidase (MAO) inhibitor or within 14 days of such treatment, concomitant use with barbiturates. Concomitant use with benzodiazepines and/or antipsychotics is permissible provided doses are stable over preceding 1 month.
- Daily use of an opioid-containing medication
- Unstable condition that is a contraindication to opioid use: Central Nervous System (CNS) depression, acute respiratory disease or impairment (acute hypoxia or hypercapnia), acute asthma or Chronic Obstructive Pulmonary Disease (COPD) exacerbation, untreated symptomatic obstructive sleep apnea, unstable cardiac arrhythmias, suspected hypovolemia, recent seizures (within 1 month), active drug abuse, abdominal disease and/or recent GI surgery (within 1 month), active gallbladder disease/biliary colic, untreated depression/suicidality, recent head injury (within 1 month), pre-existing intracranial lesion or increased intracranial pressure, untreated urinary tract obstruction, untreated hypothyroidism, hypopituitarism or Addison's disease.
- Hypotension (resting systolic blood pressure less than or equal to 80mmHg)
- Active or unstable coronary artery disease
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03401476
Start Date
May 8 2017
End Date
December 31 2019
Last Update
January 18 2018
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2