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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. |
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Register:
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EUCTR |
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Last refreshed on:
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4 August 2015 |
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Main ID: |
EUCTR2009-013112-12-GB |
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Date of registration:
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17/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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22/04/2010 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013112-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Idiopathic Dilated Cardiomyopathy
Level: LLT
Classification code 10056419
Term: Dilated Cardiomyopathy
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Change in Left Ventricular Ejection Fraction as measured with cardiac MRI (or cardiac CT) at 3 months
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Secondary Objective: The best way to deliver this novel treatment to patients.
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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.
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Secondary ID(s)
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REGENERATE/DCM/2.0
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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