World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 4 August 2015
Main ID:  EUCTR2009-013112-12-GB
Date of registration: 17/03/2010
Prospective Registration: Yes
Primary sponsor: Barts & the London NHS Trust
Public title: 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
Scientific title: 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
Date of first enrolment: 22/04/2010
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013112-12
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Idiopathic Dilated Cardiomyopathy
Level: LLT Classification code 10056419 Term: Dilated Cardiomyopathy
Intervention(s)

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 solvent for solution for injection

Primary Outcome(s)
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
Secondary Outcome(s)
Secondary ID(s)
REGENERATE/DCM/2.0
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey