Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03401476
• Date of registration: 30/04/2017
• Prospective Registration: Yes
• Primary sponsor: John Granton
• Public title: Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension
• Scientific title: Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension
• Date of first enrolment: May 8, 2017
• Target sample size: 15
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03401476
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: John Granton, MD, FRCPC
• Affiliation: University Health Network, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Morphine Sulfate

Primary Outcome(s)

Change in Borg Dyspnea Score [Time Frame: The Peak Borg Dyspnea Score will be determined over 6 minutes of observation during the conduct of each 6-minute walk test. The 6-minute walk tests and assessments of the peak Borg Dyspnea Score will be recorded within 1 and 7 days of each other.]

Secondary Outcome(s)

Change in 6-Minute Walk Distance [Time Frame: The distance travelled during each 6 minute walk will be determined at completion of the 6-minute walk test. The distance travelled during the 6-minute walk test will be recorded within 1 and 7 days of each other.]

Secondary ID(s)

MorPHine

Source(s) of Monetary Support

Please refer to primary and secondary sponsors