JPRN-jRCT1051230004招募中3 期
A multicenter randomized controlled trial of long-term thiamine supplementation in heart failure - Thiamine-HF
Tanaka Atsushi0 个研究点目标入组 118 人开始时间: 2023年4月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are eligible:
- •(1)Age 18 years or older at time of providing informed consent.
- •(2)Patients with VB1 deficiency (< 28 ng/mL).
- •(3)Outpatients with stage C heart failure.
- •(4)Patients receiving at least one standard drug for chronic heart failure (ACEI/ARB/ARNI, MRA, beta-blocker, SGLT2 inhibitor).
- •(5)Patients who understand the study protocol by documents and agree to participate in this study under their written consent.
排除标准
- •(1)New initiation of standard treatment drugs (ACEI/ARB/ARNI, MRA, beta-blocker, SGLT2 inhibitor) for chronic heart failure from 4 weeks before consent (including the same day of the week 4 weeks before) until registration, or undergoing dose modification.
- •(2)Any severe valvular heart disease (according to the severity classification of the Guidelines on the Management of Valvular Heart Disease).
- •(3)Any congenital heart disease.
- •(4)Impaired renal function, defined as eGFR <20 mL/min/1.73 m2.
- •(5)Peripheral or central neuropathy.
- •(6)Unresolved malignant tumors.
- •(7)Active infectious disease.
- •(8)Patients otherwise judged necessary to be excluded by the investigator.
研究者
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