BreatheMOR-HF:Morphine for breathlessness in heart failure Version 1
Research type
Research Study
Full title
A parallel group, double-blind, randomised placebo-controlled trial comparing the efficacy and cost-effectiveness of 20mg daily oral modified release morphine (MRM) versus placebo on the intensity of dyspnoea in patients with stable symptomatic chronic heart failure (CHF).
IRAS ID
121660
Contact name
Miriam Johnson
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Eudract number
2014-000155-81
Research summary
Chronic breathlessness, persistent despite treatment for the underlying condition, commonly causes distress for people with chronic heart failure and their carers. Low doses of morphine can help breathlessness due to cancer or lung disease, but there is little research in people with heart failure. The few studies conducted give conflicting results, although all agree that this is a safe medication under these circumstances. The trials studied morphine for 4 days only, but study included some longer term follow up, which indicated that morphine used for three months may be helpful for breathlessness.
This study aims to answer the question; “Is medium-term morphine therapy better than placebo (dummy) for the relief of chronic refractory breathlessness in people with chronic heart failure?” We will also assess the effect on: symptoms (pain and daytime sleepiness), quality of sleep, function and activity, quality of life, side-effects and cost-effectiveness.
We will randomise 346 patients to (a) placebo morphine capsules twice daily and placebo laxative or (b) modified release morphine 10mg twice daily with laxative. The study lasts for 3 months to investigate benefit and side-effects but the main analysis to assess benefit will be at 1 month. Patients may take morphine after the study end. Patients can withdraw at any point.
Eligible patients will have heart failure, be receiving standard care but are still breathless.
The main study measure is average intensity of breathlessness over the previous 24 hours using a 0-10 numerical rating scale (0-10 NRS; 0= no breathlessness, 10 = worst imaginable breathlessness). Other measures of breathlessness (unpleasantness, distress[0-10 NRS], global impression of change), other symptoms (pain, [0-10 NRS]; daytime sleepiness [Karolinska scale], sleep [Epworth Sleep Scale]), quality of life (Kansas City Cardiomyopathy Questionnaire – short form), cognitive function (Montreal Cognitive Assessment), activity (6 minute walk test [6MWT], activity monitor) and health service use will be assessed.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0277
Date of REC Opinion
16 Jun 2014
REC opinion
Further Information Favourable Opinion