Idiopathic Dilated Cardiomyopathy Level: LLT Classification code 10056419 Term: Dilated Cardiomyopathy
Conditions
Interventions
Trade Name: Granocyte Lenograstim
Product Name: GRANOCYTE - 34 million IU (Lenograstim rHuG-CSF)
Product Code: PL 12185/0002 & PL 12185/0005(WATER FOR INJECTION)
Pharmaceutical Form: Powder and sol
Sponsors
Barts & the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION 60 symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA II-III) attending a ‘Heart Failure clinic’ who are on optimal heart failure treatment, with no further treatment options, under supervision from their physician or heart failure nurse specialist. Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition. Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines). Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated. 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: Exclusions Patients who satisfy one or more of the following criteria are not suitable for inclusion in the study: • NYHA I • Documented ejection fraction >45% (any imaging modality) • The presence of cardiogenic shock • The presence of acute left and/or right sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema • Known severe pre-existent left ventricular dysfunction (ejection fraction 200mmol/L) • Neoplastic disease without documented remission within the past 5 years • Subjects of childbearing potential • Weight>140kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The design of the study seeks to determine whether a significant improvement in cardiac function and symptoms can be achieved by the relatively non-invasive procedure of G-CSF (Granocyte™) administration or whether an invasive approach requiring direct intracoronary injection provides the optimal improvement. ;Secondary Objective: The best way to deliver this novel treatment to patients.;Primary end point(s): Change in Left Ventricular Ejection Fraction as measured with cardiac MRI (or cardiac CT) at 3 months | — |
Countries
United Kingdom
Outcome results
None listed