Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial
Abstract Aims Elevated heart rate (HR) in heart failure (HF) is associated with worse outcomes, particularly in acute HF (AHF). HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction. The present trial aimed to test the hypothesis that the early HR r...
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doaj-5747c283303946d0b0babb0625ad854c2021-02-24T06:51:30ZengWileyESC Heart Failure2055-58222020-12-01764465447110.1002/ehf2.12997Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trialYang Su0Teng Ma1Zeyu Wang2Bin Dong3Chenhui Tai4Hao Wang5Fenglei Zhang6Chunxi Yan7Wei Chen8Yawei Xu9Lei Ye10Gee Jun Tye11Sang‐Bing Ong12Jian Zhang13Dachun Xu14Department of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaDepartment of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaDepartment of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaDepartment of Cardiology First Affiliated Hospital of Sun Yat‐Sen University Guangzhou ChinaDepartment of Cardiology The Second Affiliated Hospital of Nantong University 6 Northern Haierxiang Road Nantong ChinaDepartment of Cardiology, Yangpu Hospital Tongji University Shanghai 20090 ChinaDepartment of Cardiology Qidong People's Hospital Qidong Jiangsu 226200 ChinaDepartment of Cardiology Qidong People's Hospital Qidong Jiangsu 226200 ChinaDepartment of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaDepartment of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaNational Heart Research Institute Singapore National Heart Centre Singapore SingaporeInstitute for Molecular Medicine Research (INFORMM), Universiti Sains Malaysia (USM) Penang MalaysiaCentre for Cardiovascular Genomics and Medicine (CCGM), Lui Che Woo Institute of Innovative Medicine Chinese University of Hong Kong (CUHK) Hong KongState Key Laboratory of Cardiovascular Disease Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College Beijing 100037 ChinaDepartment of Cardiology, Shanghai Tenth People's Hospital Tongji University School of Medicine Shanghai 200072 ChinaAbstract Aims Elevated heart rate (HR) in heart failure (HF) is associated with worse outcomes, particularly in acute HF (AHF). HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction. The present trial aimed to test the hypothesis that the early HR reduction using ivabradine improves clinical outcomes in patients with AHF. Methods and results SHIFT‐AHF is a prospective, multi‐centre, double‐blind, randomized, placebo‐controlled trial to evaluate the efficacy and safety of ivabradine when adding to standard therapy in AHF patients (SHIFT‐AHF). The trial will include 674 AHF patients with left ventricular ejection fraction < 45% and New York Heart Association functional classes III–IV. Participants were enrolled from March 2020 and will be followed up until December 2022. Patients are randomized to treatment with ivabradine or placebo (randomization 1:1). After allocation, the dose of ivabradine is titrated according to HR. Six months' follow‐up and three control visits (7, 90, and 180 days after enrolment) are required for every participant. Assessment involves clinical examination, laboratory tests, echocardiography, electrocardiography, heart rhythm, cardiac function, and quality of life. The primary endpoint is a composite of all‐cause mortality or re‐admission due to worsening HF. Secondary endpoints include the assessments of cardiac remodelling, cardiac functional capacity, and quality of life. Conclusions The SHIFT‐AHF trial will shed further light on the role of early HR reduction using ivabradine in patients with AHF.https://doi.org/10.1002/ehf2.12997Acute heart failureIvabradineRandomized controlled trialOutcomes |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yang Su Teng Ma Zeyu Wang Bin Dong Chenhui Tai Hao Wang Fenglei Zhang Chunxi Yan Wei Chen Yawei Xu Lei Ye Gee Jun Tye Sang‐Bing Ong Jian Zhang Dachun Xu |
spellingShingle |
Yang Su Teng Ma Zeyu Wang Bin Dong Chenhui Tai Hao Wang Fenglei Zhang Chunxi Yan Wei Chen Yawei Xu Lei Ye Gee Jun Tye Sang‐Bing Ong Jian Zhang Dachun Xu Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial ESC Heart Failure Acute heart failure Ivabradine Randomized controlled trial Outcomes |
author_facet |
Yang Su Teng Ma Zeyu Wang Bin Dong Chenhui Tai Hao Wang Fenglei Zhang Chunxi Yan Wei Chen Yawei Xu Lei Ye Gee Jun Tye Sang‐Bing Ong Jian Zhang Dachun Xu |
author_sort |
Yang Su |
title |
Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial |
title_short |
Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial |
title_full |
Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial |
title_fullStr |
Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial |
title_full_unstemmed |
Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT‐AHF trial |
title_sort |
efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of shift‐ahf trial |
publisher |
Wiley |
series |
ESC Heart Failure |
issn |
2055-5822 |
publishDate |
2020-12-01 |
description |
Abstract Aims Elevated heart rate (HR) in heart failure (HF) is associated with worse outcomes, particularly in acute HF (AHF). HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction. The present trial aimed to test the hypothesis that the early HR reduction using ivabradine improves clinical outcomes in patients with AHF. Methods and results SHIFT‐AHF is a prospective, multi‐centre, double‐blind, randomized, placebo‐controlled trial to evaluate the efficacy and safety of ivabradine when adding to standard therapy in AHF patients (SHIFT‐AHF). The trial will include 674 AHF patients with left ventricular ejection fraction < 45% and New York Heart Association functional classes III–IV. Participants were enrolled from March 2020 and will be followed up until December 2022. Patients are randomized to treatment with ivabradine or placebo (randomization 1:1). After allocation, the dose of ivabradine is titrated according to HR. Six months' follow‐up and three control visits (7, 90, and 180 days after enrolment) are required for every participant. Assessment involves clinical examination, laboratory tests, echocardiography, electrocardiography, heart rhythm, cardiac function, and quality of life. The primary endpoint is a composite of all‐cause mortality or re‐admission due to worsening HF. Secondary endpoints include the assessments of cardiac remodelling, cardiac functional capacity, and quality of life. Conclusions The SHIFT‐AHF trial will shed further light on the role of early HR reduction using ivabradine in patients with AHF. |
topic |
Acute heart failure Ivabradine Randomized controlled trial Outcomes |
url |
https://doi.org/10.1002/ehf2.12997 |
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