Roman Pfister, Lars Michel, Marcel Schulze, Kai Vogtländer, Antonio Ciaccia, Martin Merz, Christian Hengstenberg
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引用次数: 0
Abstract
Introduction: Acoramidis is a novel oral transthyretin (TTR) stabilizer approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) based on the phase 3 ATTRibute-CM study (ClinicalTrials.gov identifier, NCT03860935). As the ATTR-CM therapy landscape evolves, there is a growing need to evaluate changes in disease markers and treatment response in patients who switch therapies.
Methods: ACO-SWITCH (NCT07298044) is an ongoing, prospective, open-label, multicenter, single-arm, interventional phase 4 study designed to evaluate the effects of switching from tafamidis to acoramidis in 50 adults with variant or wild-type ATTR-CM diagnosis within the past 24 months. Participants will have used tafamidis for ≥ 3 months prior to study start and after a 21-day screening period, will switch to a 6-month acoramidis treatment period. Data will be collected at weekly visits during the first month of acoramidis treatment, after 3 months, at the end of treatment, and 30 days after the end of treatment.
Planned outcomes: The primary endpoint is the change in serum TTR (sTTR) level from baseline to month 6 or time of premature treatment discontinuation, measured using immunoturbidimetry and analyzed using the one-sided paired Wilcoxon signed-rank test. Secondary endpoints include sTTR levels at different time points; changes from baseline to month 6 in cardiovascular (N-terminal pro-B-type natriuretic peptide, high-sensitivity troponin T, and retinol-binding protein 4), kidney (estimated glomerular filtration rate, creatinine, cystatin C, urinary albumin-to-creatinine ratio), and thyroid (thyroid-stimulating hormone) biomarkers; echocardiographic results; 6-minute walking distance; the Kansas City Cardiomyopathy Questionnaire overall summary score; the EuroQol 5-dimension 5-level index score; and adverse events. Statistical analyses for secondary endpoints will be explorative and descriptive. Descriptive analysis will be carried out using summary statistics for categorical and continuous data.
Conclusions: ACO-SWITCH is a prospective study in adults with ATTR-CM. The study will determine the effects of switching treatment from tafamidis to acoramidis, with a particular focus on sTTR levels. ACO-SWITCH aims to provide evidence to support clinical decision-making and guide optimal management in patients with ATTR-CM. Graphical Abstract available for this article.
期刊介绍：
Aims and Scope
Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged.
Areas of focus include, but are not limited to, ischaemic heart disease and acute cardiac care, myocardial, valvular, pericardial and congenital heart disease, vascular and pulmonary disease (including hypertension), arrhythmias, heart failure, non-invasive diagnostic techniques, and invasive and interventional cardiology as well as cardiovascular surgery.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols and short communications such as commentaries and editorials. Cardiolology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
Rapid Publication
The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of cardiovascular therapies.
Personal Service
The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Cardiology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
Publication Fees
Upon acceptance of your article for publication, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis.
Open Access
All articles published by Cardiology and Therapy are published open access.
Peer Review Process
Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor.
Preprints
We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the preprint is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website.
Copyright
Cardiology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0.
Contact
For more information about the journal, including pre-submission enquiries, please contact matthew.evans@springer.com
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