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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001063-23 | EudraCT Number |
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DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms.
DCM SUPPORT is a single centre, single arm clinical trial taking place at St Bartholomew's Hospital in London, UK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMMNC intervention arm | Other | Bone marrow derived mononuclear cells and G-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow derived mononuclear cells and G-CSF | Biological | Intra-coronary infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction | Change in left ventricular ejection fraction as measured by cardiac CT | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction | Change in left ventricular ejection fraction as measured by cardiac CT | Baseline to 12 months |
| Change in exercise capacity | Change in exercise capacity as assessed by a 6-minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40145630 | Derived | Fawaz S, Ramaseshan R, Khan S, Davies JR, Collet C, Karamasis GV, Cook CM, Jones DA, Mathur A, Keeble TR. Left Ventricular Unloading in Nonischemic Dilated Cardiomyopathy Improves Coronary Haemodynamic Reserve. Catheter Cardiovasc Interv. 2025 Jun;105(7):1719-1722. doi: 10.1002/ccd.31514. Epub 2025 Mar 27. | |
| 37190883 | Derived |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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Single arm intervention study
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| Baseline to 3 and 12 months |
| Change in heart failure symptoms | Change in heart failure symptoms as measured by NYHA classification | Baseline to 3 and 12 months |
| Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores | Change in quality of life as measured by MLHFQ (The 21-item MLHFQ uses a 6-point Likert scale, where 0 = no, 1= very little and 5= very much. The questions are intended to be representative of the ways heart failure can affect physical and emotional dimensions of quality of life) | Baseline to 3 and 12 months |
| Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires | Change in quality of life as measured by EQ-5D-5L questionnaires (the scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) | Baseline to 3 and 12 months |
| Procedural safety as assessed by in-hospital procedural related morbidity/mortality | Procedural safety as assessed by in-hospital procedural related morbidity/mortality | In-hospital procedural time |
| Change in biochemical markers of heart failure | Change in biochemical markers of heart failure as measured by change in NT-proBNP | Baseline to 3 and 12 months |
| Assessment of rates of MACE (cumulative & individual components) | Rates of MACE (all-cause death, myocardial infarction, hospitalisation for heart failure, major arrhythmias [defined as VT and VF]) | 3 and 12 months |
| Assessment of rates of stroke | Assessment of rates of stroke | 3 and 12 months |
| Assessment of peri-procedural myocardial infarction | Assessment of peri-procedural myocardial infarction as per SCAI definition measured by change in troponin (MI defined by increase in troponin >70 times upper limit of normal from baseline). | Day 0 and Day 6 |
| Change in renal function | Change in renal function from baseline at 3 and 12 months as measured by creatinine levels. | Baseline to 3 and 12 months |
| Change in inflammatory markers | Change in inflammatory markers as measured by change in C-reactive protein | Baseline to 3 and 12 months |
| Reid A, Hussain M, Veerapen J, Ramaseshan R, Hall R, Bowles R, Jones DA, Mathur A. DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular impairment. ESC Heart Fail. 2023 Aug;10(4):2664-2671. doi: 10.1002/ehf2.14393. Epub 2023 May 15. |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |