Morphine for breathlessness in heart failure

Phase 1

• Conditions: Chronic refractory breathlessness due to heart failure (NYHA Class III or IV); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000155-81-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-26
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

1. Patients with NYHA class III or IV symptoms due to heart failure as evidenced by:
a) Echo: LVSD <40% EF, or at least moderate on inspection within last 3 months
OR
b) Echo showing LVEF > 40% plus left ventricular hypertrophy, left atrial dilation or abnormal diastolic function within last 3 months
2. NT-proBNP =1000 pg/mL OR BNP =250 pg/mL within last 3 months
3. Optimal medical management of heart failure which has not changed in the previous 2 weeks (see below)
4. Adequate renal clearance within previous 2 weeks. GFR =30ml/min (see Appendix A of protocol)
5. Grade 2 or more on the modified MRC dyspnoea scale (see Appendix A of protocol)
6. Aged 18 years or over.

Optimal treatment is defined as:
oReached target dose of (or be on maximally tolerated dose of, or be intolerant of) an inhibitor of the renin-angiotensin system shown to improve prognosis AND
oReached target dose of (or be on maximally tolerated dose of, or be intolerant of) a beta adrenoceptor antagonist shown to improve prognosis AND
oReached target dose of (or be on maximally tolerated dose of, or be intolerant of) an aldosterone antagonist
As 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

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 or hypersensitivity to any of the tablet constituents 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
9. Have respiratory depression, head injury, paralytic ileus, acute abdomen, acute hepatic disease
10. Have concurrent administration of monoamine oxidase inhibitors or are within two weeks of discontinuation of their use
11. Are within the first 24 hours post-operatively

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified