A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension

Ogo Takeshi0 个研究点目标入组 30 人开始时间: 2022年6月9日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients who are at least 18 years of age at the time consent is obtained
•2) Patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)
•3) Patients who meet all of the following criteria for right heart catheterization
•1) Mean pulmonary artery pressure greater than 25 mmHg
•2) Pulmonary capillary wedge pressure or left ventricular end-diastolic pressure less than 15 mmHg
•3) Pulmonary vascular resistance greater than 3 Wood units
•4) WHO-FC III or higher
•5) Patients with fluid retention (fluid retention on physical examination or echocardiographic evidence of congestion), low cardiac output (cardiac coefficient less than 2.5 L/min/m2 ), or in need of inotropic drugs
•6) Patients with written consent from the patient

•1) Patients with cardiac disease (Eisenmenger's syndrome) who are completely dependent on a right-left shunt for life support
•2) Patients with PAH who are eligible for Calcium channel blockers
•3) Patients with pulmonary veno-occlusive disease
•4) Patients with pulmonary capillary haemangiomatosis
•5) Patients with pulmonary hypertension due to left heart disease
•6) Patients with pulmonary hypertension due to pulmonary disease and/or hypoxia
•7) Patients with pulmonary hypertension with un clear and/or multifactorial mechanisms
•8) Patients with a history of hypersensitivity to the investigational drug
•9) Pregnant or lactating women, or patients who cannot consent to contraception during the study
•10) Patients who plan to participate in other clinical trials or interventional studies during the period of this study
•11) Patients who are judged by the investigator or subinvestigator to be inappropriate to participate in this clinical trial for other reasons.

发起方

Ogo Takeshi