Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM (DCM-Support)
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- STATUS
- Recruiting
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- End date
- Jul 30, 2024
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- participants needed
- 20
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- sponsor
- Barts & The London NHS Trust
Summary
The DCM SUPPORT study is a single centre, single arm study evaluating the change in left ventricular ejection fraction with the combines use of bone marrow derived stem cells and G-CSF with a percutaneous circulatory assistance for the treatment of dilated cardiomyopathy.
Description
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).
Details
| Condition | Dilated Cardiomyopathy |
|---|---|
| Treatment | Bone marrow derived mononuclear cells and G-CSF |
| Clinical Study Identifier | NCT03572660 |
| Sponsor | Barts & The London NHS Trust |
| Last Modified on | 14 April 2022 |
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