Randomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy - REGENERATE-DCM

• Conditions: Idiopathic Dilated Cardiomyopathy; Level: LLTClassification code 10056419Term: Dilated Cardiomyopathy

• Registration Number: EUCTR2009-013112-12-GB
• Lead Sponsor: Barts & the London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 <10%) prior to randomisation
• Congenital cardiac disease
• Cardiomyopathy secondary to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia
• Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne’s progressive muscular dystrophy
• Previous cardiac surgery
• Contra-indication for bone marrow aspiration
• Known active infection
• Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), HTLV or syphilis.
• Chronic inflammatory disease requiring ongoing medication
• Serious known concomitant disease with a life expectancy of less than one year
• Follow-up impossible (no fixed abode, etc)
• Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm)
• Patients with renal impairment (Creatinine >200mmol/L)
• Neoplastic disease without documented remission within the past 5 years
• Subjects of childbearing potential
• Weight>140kg

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. <br><br>;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