Opioids in the management of breathlessness in chronic heart failure

Phase 1

• Conditions: 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: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure

• Registration Number: EUCTR2006-006718-13-GB
• Lead Sponsor: Hull and East Yorkshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-16
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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

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.

Study & Design

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