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—an update
Abstract Background Coronary artery disease (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in the progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodelli...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-12-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06931-4 |
| _version_ | 1828092545835466752 |
|---|---|
| author | Felix Nägele Leo Pölzl Michael Graber Jakob Hirsch Agnes Mayr Mathias Pamminger Felix Troger Markus Theurl Michael Schreinlechner Nikolay Sappler Christian Dorfmüller Martina Mitrovic Hanno Ulmer Michael Grimm Can Gollmann-Tepeköylü Johannes Holfeld |
| author_facet | Felix Nägele Leo Pölzl Michael Graber Jakob Hirsch Agnes Mayr Mathias Pamminger Felix Troger Markus Theurl Michael Schreinlechner Nikolay Sappler Christian Dorfmüller Martina Mitrovic Hanno Ulmer Michael Grimm Can Gollmann-Tepeköylü Johannes Holfeld |
| author_sort | Felix Nägele |
| collection | DOAJ |
| description | Abstract Background Coronary artery disease (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in the progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodelling 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 In 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. Discussion This 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 registration ClinicalTrials.gov NCT03859466. Registered on 1 March 2019. |
| first_indexed | 2024-04-11T06:30:22Z |
| format | Article |
| id | doaj.art-38f29cddb7de4a8883dcb1a06eda67b0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T06:30:22Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-38f29cddb7de4a8883dcb1a06eda67b02022-12-22T04:40:08ZengBMCTrials1745-62152022-12-0123111310.1186/s13063-022-06931-4Safety 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—an updateFelix Nägele0Leo Pölzl1Michael Graber2Jakob Hirsch3Agnes Mayr4Mathias Pamminger5Felix Troger6Markus Theurl7Michael Schreinlechner8Nikolay Sappler9Christian Dorfmüller10Martina Mitrovic11Hanno Ulmer12Michael Grimm13Can Gollmann-Tepeköylü14Johannes Holfeld15Department of Cardiac Surgery, Medical University of InnsbruckDepartment of Cardiac Surgery, Medical University of InnsbruckDepartment of Cardiac Surgery, Medical University of InnsbruckDepartment of Cardiac Surgery, Medical University of InnsbruckDepartment of Radiology, Medical University of InnsbruckDepartment of Radiology, Medical University of InnsbruckDepartment of Radiology, Medical University of InnsbruckDepartment of Internal Medicine III, Medical University of InnsbruckDepartment of Internal Medicine III, Medical University of InnsbruckDepartment of Internal Medicine III, Medical University of InnsbruckHeart Regeneration TechnologiesHeart Regeneration TechnologiesDepartment of Medical Statistics, Informatics and Health EconomicsDepartment of Cardiac Surgery, Medical University of InnsbruckDepartment of Cardiac Surgery, Medical University of InnsbruckDepartment of Cardiac Surgery, Medical University of InnsbruckAbstract Background Coronary artery disease (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in the progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodelling 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 In 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. Discussion This 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 registration ClinicalTrials.gov NCT03859466. Registered on 1 March 2019.https://doi.org/10.1186/s13063-022-06931-4ShockwaveCABGIschemic heart diseaseHeart failureClinical trial |
| spellingShingle | Felix Nägele Leo Pölzl Michael Graber Jakob Hirsch Agnes Mayr Mathias Pamminger Felix Troger Markus Theurl Michael Schreinlechner Nikolay Sappler Christian Dorfmüller Martina Mitrovic Hanno Ulmer Michael Grimm Can Gollmann-Tepeköylü Johannes Holfeld 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—an update Trials Shockwave CABG Ischemic heart disease Heart failure Clinical trial |
| title | 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—an update |
| title_full | 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—an update |
| title_fullStr | 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—an update |
| title_full_unstemmed | 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—an update |
| title_short | 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—an update |
| title_sort | 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 an update |
| topic | Shockwave CABG Ischemic heart disease Heart failure Clinical trial |
| url | https://doi.org/10.1186/s13063-022-06931-4 |
| work_keys_str_mv | AT felixnagele safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT leopolzl safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT michaelgraber safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT jakobhirsch safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT agnesmayr safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT mathiaspamminger safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT felixtroger safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT markustheurl safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT michaelschreinlechner safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT nikolaysappler safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT christiandorfmuller safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT martinamitrovic safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT hannoulmer safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT michaelgrimm safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT cangollmanntepekoylu safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate AT johannesholfeld safetyandefficacyofdirectcardiacshockwavetherapyinpatientswithischemiccardiomyopathyundergoingcoronaryarterybypassgraftingthecasthftrialstudyprotocolforarandomizedcontrolledtrialanupdate |