VERINA: A Phase IV Prospective Multicenter Study of Vericiguat in Indian Patients with Worsening Heart Failure and Reduced Ejection Fraction.
IF 3.2
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
引用次数: 0
Abstract
Introduction: Patients with heart failure (HF) with reduced ejection fraction (HFrEF) remain at high risk of cardiovascular (CV) death and hospitalization following a worsening heart-failure event. Data on vericiguat, a prescription oral medication used to treat symptomatic chronic HF, in adult Indian patients are limited.
Methods: Adults with chronic HFrEF and a worsening heart-failure event were enrolled in a prospective, multicenter, open-label, single-arm phase IV study design. Participants received vericiguat in addition to foundational medical therapy (FMT) and were followed for approximately 48 weeks. The primary endpoint was CV death or first hospitalization for HF. Secondary endpoints included CV death, first hospitalization for HF, all-cause death or first hospitalization for HF, all-cause death and safety outcomes.
Results: Of 231 patients who underwent screening, 205 received vericiguat and comprised the safety analysis set; of these, 203 patients constituted the full analysis set. The mean age of participants was 58 years. Baseline use of angiotensin receptor-neprilysin inhibitors and sodium-glucose cotransporter-2 inhibitors was 52.7% and 75.6%, respectively. At week 48, Kaplan-Meier (KM) estimates were 10.1% for the primary endpoint, 3.3% for CV death, 9.1% for first hospitalization for HF, 11.5% for all-cause death or first hospitalization for HF, and 5.9% for all-cause death. Attainment of the target dose was 91.6%, with 69.5% of participants reaching and maintaining 10 mg by week 4. Study drug-related adverse events (AEs) were reported in 3.4% of participants, and treatment-emergent AEs requiring discontinuation in 2.0% of participants.
Conclusion: In Indian patients with worsening HFrEF, high target-dose attainment and no new safety signals were observed during 48 weeks of vericiguat treatment.
Trial registration: Clinical Trials Registry-India: CTRI/2022/11/047636.
VERINA: Vericiguat在印度心力衰竭恶化和射血分数降低患者中的4期前瞻性多中心研究。
导论：心力衰竭（HF）伴射血分数（HFrEF）降低的患者在心力衰竭事件恶化后仍有心血管（CV）死亡和住院的高风险。vericiguat是一种用于治疗症状性慢性心衰的处方口服药物，在印度成年患者中的数据有限。方法：成人慢性HFrEF和心衰恶化纳入前瞻性、多中心、开放标签、单臂IV期研究设计。参与者在基础药物治疗（FMT）的基础上接受验证治疗，随访约48周。主要终点是CV死亡或首次因心衰住院。次要终点包括CV死亡、首次因HF住院、全因死亡或首次因HF住院、全因死亡和安全性结局。结果：在231例接受筛查的患者中，205例接受了验证，并构成了安全性分析集；其中203例患者构成完整的分析集。参与者的平均年龄为58岁。血管紧张素受体-奈普利素抑制剂和钠-葡萄糖共转运蛋白-2抑制剂的基线使用率分别为52.7%和75.6%。在第48周，Kaplan-Meier （KM）估计主要终点为10.1%，CV死亡为3.3%，HF首次住院为9.1%，HF全因死亡或首次住院为11.5%，HF全因死亡为5.9%。达到目标剂量的比例为91.6%，其中69.5%的参与者在第4周达到并维持10 mg。3.4%的参与者报告了研究药物相关不良事件（ae）， 2.0%的参与者报告了治疗发生的ae，需要停药。结论：在印度HFrEF恶化患者中，在48周的验证治疗期间，未观察到高靶剂量达到和新的安全性信号。临床试验注册：印度临床试验注册：CTRI/2022/11/047636。
本文章由计算机程序翻译，如有差异，请以英文原文为准。
求助全文
约1分钟内获得全文
求助全文
来源期刊
Cardiology and Therapy
CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
5.30
自引率
0.00%
发文量
38
审稿时长
6 weeks
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
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
