ISRCTN41349358Terminated未知
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 severely symptomatic chronic heart failure (CHF)
Hull and East Yorkshire Hospitals NHS Trust (UK)0 sites45 target enrollmentStarted: May 19, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31389157 (added 02/09/2019)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current exclusion criteria as of 06/07/2015:
- •1. Patients with New York Heart Association (NYHA) class III or IV symptoms due to heart failure as evidenced by:
- •1.1. Echo: left ventricular systolic dysfunction (LVSD) <40% ejection fraction (EF), or at least moderate on inspection, OR
- •1.2. Echo showing left ventricular ejection fraction (LVEF) > 40% plus left ventricular hypertrophy, left atrial dilation or abnormal diastolic function
- •2. N-terminal portion of B-type natriuretic peptides (NT-proBNP) =1000 pg/mL OR BNP =250 pg/mL within last 3 months
- •3. Optimal medical treatment of heart failure which has not changed in the previous 2 weeks
- •4. Adequate renal clearance within previous 2 weeks. glomerular filtration rate (GFR) =30ml/min
- •5. Grade 2 or more on the modified MRC dyspnoea scale
- •6. Aged 18 years or over
- •Optimal medical management
- •This will be assessed by the clinician responsible for the usual care of the patient and reviewed by the study doctor at the recruiting centre prior to study entry. Sub-optimal treatment will be addressed before study entry. Treatment (including dose of diuretic) must be stable for the two weeks prior to randomisation. Optimal treatment for patients with left ventricular dysfunction is defined as:
- •1. Reached target dose (or be on maximally tolerated dose, or be intolerant) of an inhibitor of the renin-angiotensin system shown to improve prognosis
- •2. Reached target dose (or be on maximally tolerated dose, or be intolerant) of a beta adrenoceptor antagonist shown to improve prognosis
- •3. Reached target dose (or be on maximally tolerated dose, or be intolerant) of an aldosterone antagonist
- •Optimal treatment for patients with normal left ventricular function will be as assessed by their usual clinician.
- •Previous exclusion criteria:
- •1. Patients with New York Heart Association (NYHA) class III or IV symptoms due to heart failure as evidenced by:
- •1.1. Echo: left ventricular systolic dysfunction (LVSD) <40% ejection fraction (EF), or at least moderate on inspection within last 3 months, OR
- •1.2. Echo showing left ventricular ejection fraction (LVEF) > 40% plus left ventricular hypertrophy, left atrial dilation or abnormal diastolic function within last 3 months
- •2. N-terminal portion of B-type natriuretic peptides (NT-proBNP) =1000 pg/mL OR BNP =250 pg/mL within last 3 months
- •3. Optimal medical treatment of heart failure which has not changed in the previous 2 weeks
- •4. Adequate renal clearance within previous 2 weeks. glomerular filtration rate (GFR) =30ml/min
- •5. Grade 2 or more on the modified MRC dyspnoea scale
- •6. Aged 18 years or over
- •Optimal medical management
- •This will be assessed by the clinician responsible for the usual care of the patient and reviewed by the study doctor at the recruiting centre prior to study entry. Sub-optimal treatment will be addressed before study entry. Treatment (including dose of diuretic) must be stable for the two weeks prior to randomisation. Optimal treatment is defined as:
- •1. Reached target dose (or be on
Exclusion Criteria
- •Patients who:
- •1. Are unable to provide informed consent
- •2. Are unable to complete baseline study questionnaires even with the assistance of the study nurse
- •3. Have co-existing malignant disease only if this would affect the study in the investigators? opinion
- •4. Have used morphine-based medications regularly (that is, most days) within the last month above the study dose.
- •5. Have known true morphine allergies as assessed by a clinician.
- •6. Have known central hypoventilation syndrome
- •7. Have been involved in another medicinal trial (CTIMP) within the past four weeks
- •8. Are pregnant or lactating
Investigators
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