跳至主要内容
临床试验/NCT05553015
NCT05553015招募中不适用

A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)

Chinese Pulmonary Vascular Disease Research Group1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
1-year transplant event-free survival in patients with pulmonary hypertension

研究概览

简要总结

A Real-World Registry investigate Treprostinil sodium used in patients with Pulmonary Hypertension (Re-TRIUMPH).

详细描述

This study is a multicenter, prospective, single-arm, observational, real-world study conducted in China. Patients who are at least 18 years of age, have been diagnosed with pulmonary hypertension (PH), agree to participate and meet the eligibility requirement will be enrolled in 20 pulmonary vascular centers across the country for the medically reasonable use of intravenous (or subcutaneous) Treprostinil injections. In the event that eligible patients are enrolled in the study, all aspects will be carried out in an observational manner, and no additional methods or procedures will be necessary. The patient and the physician will jointly determine the clinical management of the patient, including the length of treatment. Patients will be followed up for an observation period of at least 1 year. As part of standard clinical practice, patient data will be collected at the first appointment and every three to six months thereafter. After one year of follow-up, data collection will cease.The main purpose is to evaluate the efficacy and adverse reactions of subcutaneous (intravenous) prostacyclin in the treatment of pulmonary hypertension under current clinical practice. The secondary objectives is to understand the drug treatment plan of treprostinil in clinical practice of patients with pulmonary arterial hypertension in China and to understand the efficacy and adverse reactions of treprostinil in the treatment of patients with different types of pulmonary hypertension.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with pulmonary hypertension who consent to receiving Treprostinil injection;
  • Patients who must be over the age of 18;
  • The informed consent form must be signed.

排除标准

  • Patients who have received Treprostinil Injection for less than two weeks;
  • Patients who have used Treprostinil within the past three months;
  • Any situation that the investigator believes could affect the interpretation of the study results or pose a risk to patients using Treprostinil.

结局指标

主要结局

1-year transplant event-free survival in patients with pulmonary hypertension

时间窗: 1 year

1-year transplant event-free survival in patients with pulmonary hypertension

次要结局

  • Incidence of adverse events(1 year)

研究者

发起方
Chinese Pulmonary Vascular Disease Research Group
申办方类型
Other
责任方
Sponsor

研究点 (1)

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