Goreisan for Heart Failure Trial - GOREISAN-HF Trial

Ono Koh0 个研究点目标入组 2,192 人开始时间: 2020年12月22日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Confirmed congestive heart failure (CHF) by Framingham criteria
•2. CHF patients with symptoms and signs of fluid overload (i.e., lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray)
•3. Elevated NT-proBNP>=300 pg/mL OR BNP>=100 pg/mL at enrollment
•4. Patients>=20 years of age, male or female
•5. Provision of signed informed consent before any assessment is performed

•1. Valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization
•2. Implantation of a cardiac CRT within 12 weeks prior to enrollment or intent to implant a CRT device
•3. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
•4. End-stage renal failure (eGFR <15 mL/min/1.73m2) at enrollment
•5. Patients who are expected to have a life prognosis of 6 months or less
•6. Acute coronary syndrome at screening
•7. Women of child-bearing potential OR women who have a positive pregnancy test at enrolment or randomization
•8. Patients who are being treated with Kampo (herbal medicine) at enrollment
•9. Confirmed poor tolerability of Goreisan (including cinnamon allergy)
•10. Patients who are not appropriate for the participation of the study

发起方

Ono Koh