DCM SUPPORT Study
Research type
Research Study
Full title
PHASE II STUDY ASSESSING THE COMBINED USE OF AUTOLOGOUS BONE MARROW DERIVED MONONUCLEAR CELLS AND G-CSF WITH PERCUTANEOUS CIRCULATORY ASSISTANCE IN THE TREATMENT OF DILATED CARDIOMYOPATHY
IRAS ID
224790
Contact name
Anthony Mathur
Contact email
Sponsor organisation
Queen Mary Innovation Centre, Queen Mary University of London
Eudract number
2018-001063-23
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Dilated cardiomyopathy (DCM) is the leading cause of heart failure in younger patients and is the most common indication for cardiac transplantation. Although a proportion of DCM patients recover heart function, the majority suffer a progressive decline in left ventricular ejection fraction (LVEF – pumping performance of the main chamber in the heart) with high levels of morbidity and mortality.
The REGENERATE-DCM trial yielded encouraging results with an improvement in LVEF and symptoms for participants compared to placebo. This trial utilised bone marrow derived mononuclear cells (BMMNC) following 5 days of G-CSF administration (a hormone that stimulates bone marrow to make more cells) and ultimately these cells were infused down the coronary arteries of participants (intracoronary infusion). This trial looked at patients with moderate LVEF (35-45%). Patients with severely impaired LVEF (≤35%) have been excluded from clinical trials even though it is likely they would derive most benefit. We therefore propose the DCM SUPPORT Study where intracoronary infusion of BMMNC and adjunctive G-CSF will be utilised in a patient population with DCM and LVEF ≤30%. A mechanical pump will also be utilised to provide peri-procedural blood pressure support during the infusion of BMMNC and improve procedural safety. This device helps the patient’s heart pump blood around the body.
The DCM SUPPORT study is a single centre, single arm, phase II pilot study. The primary endpoint will be a change in LVEF from baseline measured by a CT scan of the heart at 3 months. The secondary endpoints include change in LVEF from baseline measured by a CT scan of the heart at 12 months, in-hospital procedural related morbidity / mortality and assessment of major adverse cardiac events (MACE; death, heart attack, need for repeat heart revascularisation), change in exercise capacity and NYHA class at 3 months and 12 months respectively. The NYHA classification is a quantitative way of assessing a patient’s heart failure symptoms. It places patients into one of four categories (I – IV).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0195
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion