Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.
Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.
ESC Heart Fail. 2023 Aug;10(4):2664-2671. doi: 10.1002/ehf2.14393. Epub 2023 May 15.
The DCM Support trial (NCT03572660) uses a percutaneous circulatory support device (Impella CP, Abiomed, Danvers, MA, USA) to improve the safety of an intracoronary cell infusion procedure in patients with dilated cardiomyopathy (DCM) and a severely reduced left ventricular ejection fraction (LVEF).
DCM Support is a single-site, single-arm Phase II trial enrolling 20 symptomatic DCM patients with an LVEF ≤ 35% despite optimal medical and device therapy. After 5 days of granulocyte colony-stimulating factor therapy and a subsequent bone marrow aspiration, patients undergo an intracoronary infusion of autologous bone-marrow-derived mononuclear cells. The Impella CP device is used to provide haemodynamic support during the infusion procedure. The trial's primary endpoint is change in LVEF from baseline at 3 months. Secondary efficacy endpoints are change in LVEF from baseline at 12 months, and change in exercise capacity, New York Heart Association class, quality of life, and N-terminal pro-B-type natriuretic peptide levels from baseline at 3 and 12 months. Safety endpoints include procedural safety and major adverse cardiac events at 3 and 12 months.
This is the first trial to assess the safety and efficacy of cytokine and autologous intracoronary cell therapy with a procedural circulatory support device for patients with severe left ventricular impairment. This novel combination may allow us to target a patient population most at need of this therapy.
DCM 支持试验（NCT03572660）使用经皮循环支持装置（Impella CP，Abiomed，Danvers，MA，美国）来提高扩张型心肌病（DCM）和严重左心室射血分数（LVEF）降低患者冠状动脉内细胞输注程序的安全性。
DCM 支持是一项单中心、单臂 II 期试验，纳入了 20 名有症状的 DCM 患者，这些患者尽管接受了最佳的药物和器械治疗，但 LVEF 仍≤35%。在接受 5 天粒细胞集落刺激因子治疗和随后的骨髓抽吸后，患者接受冠状动脉内输注自体骨髓源性单核细胞。Impella CP 装置用于在输注过程中提供血液动力学支持。试验的主要终点是 3 个月时 LVEF 与基线相比的变化。次要疗效终点是 12 个月时 LVEF 与基线相比的变化，以及 3 和 12 个月时运动能力、纽约心脏协会（NYHA）心功能分级、生活质量和 N 末端 pro-B 型利钠肽水平与基线相比的变化。安全性终点包括 3 个月和 12 个月时的程序安全性和主要不良心脏事件。
这是第一项评估细胞因子和自体冠状动脉内细胞治疗与程序循环支持装置联合用于严重左心室功能障碍患者的安全性和疗效的试验。这种新的联合治疗可能使我们能够针对最需要这种治疗的患者群体。
