jRCT1051230206招募中不适用
Vericiguat on Heart Failure with reduced Ejection Fraction with Pulmonary Hypertension
未提供0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients must meet all of the following criteria at the time of consent.
- •Left ventricular ejection fraction (LVEF) less than 40% on echocardiography performed within 12 months.
- •Patients must be on standard treatment for chronic heart failure, with stable doses within 1 week before catheterization and during the screening period before enrollment.
- •Patients with combined post- and pre-capillary pulmonary hypertension (CpcPH: mean pulmonary artery pressure > 20 mmHg, pulmonary wedge pressure > 15 mmHg, pulmonary vascular resistance > 160 dynes-sec-cm-5) at a right heart catheterization performed within 28 days.
- •Patients must be at least 18 years of age (as of the date written consent is obtained).
- •Written consent has been obtained from the patient before enrollment.
排除标准
- •Patients must not be in conflict with any of the following criteria at the time consent is obtained.
- •Patients with a clinically unstable condition at the time of enrollment as defined below
- •a) Received an intravenous therapeutic agent within 24 hours, or
- •b) Systolic blood pressure less than 100 mmHg or symptomatic hypotension.
- •Patients who must receive concomitant long-acting nitrates or NO donors.
- •Patients requiring use of phosphodiesterase 5 inhibitors.
- •Patients requiring use of other pulmonary vasodilators (endothelin receptor antagonists, prostacyclines, prostacyclin receptor agonists).
- •Patients requiring use of other sGC stimulants.
- •Patients with known allergy or hypersensitivity to sGC stimulants.
- •Patients awaiting heart transplantation, receiving continuous intravenous inotropic infusion, or who have or will have a ventricular assist device implantation.
- •Patients with acute coronary syndrome within 60 days before enrollment or patients who have undergone coronary revascularization within 60 days before enrollment.
- •Patients with serious complications (severe liver dysfunction such as hepatic encephalopathy, patients with severe pulmonary disease requiring continuous home oxygenation, eGFR less than 15 mL/min/1.73 m2 or patients undergoing dialysis, patinets with life expectancy less than 6 months due to malignancy or extra-cardiac disease).
- •Pregnant or lactating women, or women of childbearing potential (within 12 months of last menstrual period) who are unable to consent to contraception during the study period.
- •Patients who plans to participate in a study involving another intervention during the study period.
- •Patients who plans to undergo catheter intervention or surgery during the study period after enrollment.
- •For other safety reasons, the principal investigator or subinvestigator determines that participation in this study is inappropriate.
结局指标
主要结局
-
Change in pulmonary vascular resistance (PVR)
次要结局
未报告次要终点
研究者
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