Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial

Trials

Study Protocol

Martina Mitrovic¹  Christian Dorfmüller²  Daniela Lobenwein³  Johannes Holfeld³  Felix Nägele³  Michael Grimm³  Can Gollmann-Tepeköylü³  Michael Graber³  Jakob Hirsch³  Leo Pölzl³  Markus Theurl⁴  Michael Schreinlechner⁴  Agnes Mayr⁵  Matthias Pamminger⁵ 

[1] Clinical Trial Center, Medical University of Innsbruck, Innrain 52, 6020, Innsbruck, Austria;Heart Regeneration Technologies GmbH, Innsbruck, Austria;University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria;University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria;University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria;

关键词: Shockwave;    CABG;    Ischemic heart disease;    Heart failure;    Clinical trial;   

DOI  :  10.1186/s13063-020-04369-0

 received in 2019-09-27, accepted in 2020-05-05,  发布年份 2020

来源: Springer

【 摘 要 】

BackgroundCoronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure. Available neurohumoral treatment strategies aim at the improvement of symptoms. Despite extensive research, therapeutic options for myocardial regeneration, including (stem)-cell therapy, gene therapy, cellular reprogramming or tissue engineering, remain purely experimental. Thus, there is an urgent clinical need for novel treatment options for inducing myocardial regeneration and improving left-ventricular function in ischemic cardiomyopathy.Shockwave Therapy (SWT) is a well-established regenerative tool that is effective for the treatment of chronic tendonitis, long-bone non-union and wound-healing disorders. In preclinical trials, SWT regenerated ischemic myocardium via the induction of angiogenesis and the reduction of fibrotic scar tissue, resulting in improved left-ventricular function.Methods/designIn this prospective, randomized controlled, single-blind, monocentric study, 80 patients with reduced left-ventricular ejection fraction (LVEF≤ 40%) are subjected to coronary-artery bypass-graft surgery (CABG) surgery and randomized in a 1:1 ratio to receive additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment (control group; 40 patients). This study aims to evaluate (1) the safety and (2) the efficacy of cardiac SWT as adjunctive treatment during CABG surgery for the regeneration of ischemic myocardium. The primary endpoints of the study represent (1) major cardiac events and (2) changes in left-ventricular function 12 months after treatment. Secondary endpoints include 6-min Walk Test distance, improvement of symptoms and assessment of quality of life.DiscussionThis study aims to investigate the safety and efficacy of cardiac SWT during CABG surgery for myocardial regeneration. The induction of angiogenesis, decrease of fibrotic scar tissue formation and, thus, improvement of left-ventricular function could lead to improved quality of life and prognosis for patients with ischemic heart failure. Thus, it could become the first clinically available treatment strategy for the regeneration of ischemic myocardium alleviating the socio-economic burden of heart failure.Trial registrationClinicalTrials.gov, ID: NCT03859466. Registered on 1 March 2019.

【 授权许可】

CC BY   
© The Author(s) 2020

【 图 表 】

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Fig. 4