Patients known to the Academic Unit of Cardiology that have symptomatic chronic heart failure (New York Heart Association grading 3-4) despite maximal medical treatment. MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Trade Name: Oramorph oral solution
Product Name: Oramorph
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Trade N
Sponsors
Hull and East Yorkshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with: Heart failure grade NYHA III/IV with Left Ventricular (LV) dysfunction confirmed by echocardiography. Heart failure from any aetiology with stable NYHA status for at least one month. Optimal (and unchanged over previous one month) medical management of their heart failure (diuretic and ACE inhibitor/AII antagonist). Adequate renal clearance (GFR >30ml/min). Aged 18 years or over. Provided written informed consent and able to complete patient assessments. An estimated survival of more than eight weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who: Are unable to complete patient related information on entry. Have significant co-existing lung disease (e.g. COPD, Asthma, Lung fibrosis) contributing significantly to the patients’ breathlessness. Have significant renal impairment (GFR <=30ml/min). Are unable to provide informed consent. Have used morphine based medications for breathlessness within the last month. Have known true morphine allergies. Patients who have conditions contraindicated in the Summary of Product Characteristics (SmPCs) for Oramorph and Oxynorm, namely: Respiratory depression, obstructive airways disease, acute and chronic bronchial asthma, cor pulmonale, hypercarbia, acute hepatic disease, moderate to severe hepatic impairment, acute alcoholism, acute abdomen, delayed gastric emptying, chronic constipation, head injury, coma, convulsive disorders, raised intracranial pressure, paralytic ileus, severe renal impairment, known hypersensitivity to product constituents and those receiving Mono-amine Oxidase inhibitors (MAOIs) or within 2 weeks of cessation of these drugs. Patients who are planning to undergo a surgical or interventional procedure, those taking a medicinal product with a known interaction with opioid based compounds, and women who are pregnant or lactating will also be excluded. Patients will be withdrawn from the study on: Withdrawal of patient consent. Withdrawal of the patient by the treating physician or medical researcher due to the patient no longer meeting the eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if opioids (oramorph or oxynorm) reduce the severity of breathlessness experienced by chronic heart failure patients on maximal medical therapy with diuretics and ACE inhibitors / Angiotensin II receptor antagonists. The severity of breathlessness will be measured using the validated Borg score for breathlessness and 11 point numerical ratings scales.;Secondary Objective: To assess the relative benefits of oral morphine and oral oxycodone in the management of breathlessness in advanced heart failure. To monitor any subsequent changes in distress caused by breathlessness, satisfaction, coping, physical function and quality of life measurements on treatment. To assess the impact of morphine or oxycodone on quality of life in heart failure. To confirm tolerability of therapy in this patient population and to assess relative merits of morphine versus oxycodone. To explore the characteristics of breathlessness in heart failure patients. ;Primary end point(s): Primary: Severity of breathlessness as measured by the validated Borg score for breathlessness and NRS for breathlessness (average and worse over past 24 hours and current level) compared for oramorph, oxycodone and placebo. Secondary: 1) Distress from breathlessness as measured by the NRS score for distress. 2) Satisfaction and coping with breathlessness as measured by the NRS scores for satisfaction and coping with breathlessness. 3) Assessment of the characteristics of breathlessness in heart failure patients by using the descriptors for breathlessness. 4) Adverse effects as measured by NRS scores for nausea and drowsiness, constipation assessment, use of concomitant medications and identification through self report of other events that may or may not be attributable to study drug. 5) Quality of life scores as measured by the validated SF-12 Quality of Life Questionnaire. | — |
Countries
United Kingdom
Outcome results
None listed