Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus (TOP-HFPEF Trial).

IF 3.1 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiovascular Drugs and Therapy Pub Date : 2025-02-01 Epub Date: 2024-05-10 DOI:10.1007/s10557-024-07576-y

Shin Ito, Yuri Nakajima, Hiroki Fukuda, Chisato Izumi, Gaku Nakazawa, Hajime Yamashita, Hideo Matsuhisa, Moriaki Inoko, Shigeru Toyoda, Shin Takiuchi, Toru Kataoka, Yasuhiro Izumiya, Yukio Abe, Takashi Sozu, Yasushi Sakata, Masanori Emoto, Teruo Inoue, Masafumi Kitakaze

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引用次数: 0

Abstract

Background: Recent large clinical trials have revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes not only in patients with heart failure with reduced ejection fraction, but also in patients with heart failure with mildly reduced or preserved ejection fraction (HFpEF). However, the effect of SGLT2 inhibitors on left ventricular (LV) diastolic function is still controversial.

Methods and results: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus. The participants are randomly assigned (1:1) to the tofogliflozin group (20 mg once daily) or the control group (administration or continuation of antidiabetic drugs other than SGLT2 inhibitors). The estimated number of patients to be enrolled in this trial is 90 in total (45 in each group). The participants are followed up for 52 weeks with tofogliflozin or control drugs. The primary endpoint is the change in E/e' assessed by echocardiography from the baseline to the end of this study (52 weeks). This trial will also evaluate the effects of tofogliflozin on cardiovascular events, biomarkers, other echocardiographic parameters, the occurrence of atrial fibrillation, and renal function.

Conclusions: The TOP-HFPEF trial will clarify the efficacy of an SGLT2 inhibitor, tofogliflozin, on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus.

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调查托非格列净对射血分数保留型心力衰竭合并 2 型糖尿病患者左心室舒张功能障碍疗效的前瞻性、多中心、双臂临床试验（TOP-HFPEF 试验）的原理与设计。

背景：最近的大型临床试验显示，钠-葡萄糖共转运体2（SGLT2）抑制剂不仅能改善射血分数降低型心力衰竭患者的心血管预后，还能改善射血分数轻度降低或保留型心力衰竭（HFpEF）患者的心血管预后。然而，SGLT2 抑制剂对左心室舒张功能的影响仍存在争议：TOP-HFPEF试验（Tofogliflozin对射血分数保留型心力衰竭合并2型糖尿病患者左室舒张功能障碍的疗效）是一项由研究者发起的多中心、双臂、开放标签、确证性临床研究，旨在探讨SGLT2抑制剂对HFpEF合并2型糖尿病患者左室舒张功能的影响。参与者被随机分配（1:1）到托福格列单抗组（20 毫克，每天一次）或对照组（服用或继续服用 SGLT2 抑制剂以外的抗糖尿病药物）。该试验预计共招募 90 名患者（每组 45 人）。参与者将接受为期 52 周的托福格列净或对照药物随访。主要终点是通过超声心动图评估从基线到研究结束（52 周）期间 E/e' 的变化。该试验还将评估托非格列净对心血管事件、生物标志物、其他超声心动图参数、心房颤动发生率和肾功能的影响：TOP-HFPEF试验将明确SGLT2抑制剂托非格列净对HFpEF和2型糖尿病患者左心室舒张功能的疗效。

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来源期刊

Cardiovascular Drugs and Therapy 医学-心血管系统

CiteScore

8.30

自引率

0.00%

发文量

110

审稿时长

4.5 months

期刊介绍： Designed to objectively cover the process of bench to bedside development of cardiovascular drug, device and cell therapy, and to bring you the information you need most in a timely and useful format, Cardiovascular Drugs and Therapy takes a fresh and energetic look at advances in this dynamic field. Homing in on the most exciting work being done on new therapeutic agents, Cardiovascular Drugs and Therapy focusses on developments in atherosclerosis, hyperlipidemia, diabetes, ischemic syndromes and arrhythmias. The Journal is an authoritative source of current and relevant information that is indispensable for basic and clinical investigators aiming for novel, breakthrough research as well as for cardiologists seeking to best serve their patients. Providing you with a single, concise reference tool acknowledged to be among the finest in the world, Cardiovascular Drugs and Therapy is listed in Web of Science and PubMed/Medline among other abstracting and indexing services. The regular articles and frequent special topical issues equip you with an up-to-date source defined by the need for accurate information on an ever-evolving field. Cardiovascular Drugs and Therapy is a careful and accurate guide through the maze of new products and therapies which furnishes you with the details on cardiovascular pharmacology that you will refer to time and time again.