Chronic heart failure Circulatory System Chronic Heart Failure
Conditions
Interventions
Please note that as of 29/04/2008 the anticipated start date of this trial was changed to 01/05/2008
the previous start date was 01/07/2007.
The two active intervention arms involve low dose oral liquid morphine (oramorph 5 mg four times a day [QDS]) and oral oxycodone liquid (oxynorm 2.5 mg QDS).
Sponsors
Hull and East Yorkshire Hospitals NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. New York Heart Association (NYHA) grade three to four chronic heart failure with systolic dysfunction on echocardiography 2. Receiving optimal medical management (diuretics and Angiotensin Converting Enzymes [ACE] inhibitors/angiotensin 2 antagonists) stable for the past month 3. Aged 18 years and over
Exclusion criteria
Exclusion criteria: 1. Inadequate renal function (Glomerular Filtration Rate [GFR] less than 30 ml/min on Cockroft/Gault formula) 2. Morphine allergy 3. Currently receiving opioid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of breathlessness as measured by the Borg validated score for breathlessness and 11 point Numerical Rating Scale (worst, average and current readings), measured daily whilst taking the trial medications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Distress from breathlessness, measured on days one and four for each trial medication (the first and last days participants take it) 2. Satisfaction and coping, measured daily whilst taking the trial medications 3. Breathlessness descriptors, measured on days one and four for each trial medication (the first and last days participants take it) 4. Adverse effect scores, measured daily whilst taking the trial medications 5. Quality of life, measured on days one and four for each trial medication (the first and last days participants take it) | — |
Countries
United Kingdom
Outcome results
None listed