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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).
Ito, Shin; Nakajima, Yuri; Fukuda, Hiroki; Izumi, Chisato; Nakazawa, Gaku; Yamashita, Hajime; Matsuhisa, Hideo; Inoko, Moriaki; Toyoda, Shigeru; Takiuchi, Shin; Kataoka, Toru; Izumiya, Yasuhiro; Abe, Yukio; Sozu, Takashi; Sakata, Yasushi; Emoto, Masanori; Inoue, Teruo; Kitakaze, Masafumi.
Afiliación
  • Ito S; Department of Clinical Research and Development, National Cerebral and Cardiovascular Center, Suita, Japan.
  • Nakajima Y; Department of Heart Failure and Transplant, National Cerebral and Cardiovascular Center, Suita, Japan.
  • Fukuda H; Department of Clinical Research and Development, National Cerebral and Cardiovascular Center, Suita, Japan.
  • Izumi C; Cardiovascular Center, Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai, Osaka, Japan.
  • Nakazawa G; Department of Heart Failure and Transplant, National Cerebral and Cardiovascular Center, Suita, Japan.
  • Yamashita H; Department of Cardiology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan.
  • Matsuhisa H; Department of Cardiology, Baba Memorial Hospital, Sakai, Japan.
  • Inoko M; Department of Cardiovascular Medicine, Sakai City Medical Center, Sakai, Japan.
  • Toyoda S; Cardiovascular Center, Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai, Osaka, Japan.
  • Takiuchi S; Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Japan.
  • Kataoka T; Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan.
  • Izumiya Y; Division of Cardiology, Bell Land General Hospital, Sakai, Japan.
  • Abe Y; Department of Cardiovascular Medicine, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
  • Sozu T; Department of Cardiology, Osaka City General Hospital, Osaka, Japan.
  • Sakata Y; Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.
  • Emoto M; Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Inoue T; Department of Metabolism, Endocrinology and Molecular Medicine, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
  • Kitakaze M; Japan Red Cross Society, Nasu Red Cross Hospital, Otawara, Japan.
Cardiovasc Drugs Ther ; 2024 May 10.
Article en En | MEDLINE | ID: mdl-38727896
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 (11) 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cardiovasc Drugs Ther Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cardiovasc Drugs Ther Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos