LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Recovery of clinical stability criteria
研究概览
简要总结
The study is designed as a non-interventional, multicenter, prospective single-arm study to observe the therapy with REMODULIN (Treprostinil) applicated by an implantable pump in patients with pulmonary arterial hypertension (PAH).
详细描述
Patients that suffer from progressing PAH are medicated with intravenous prostanoids since the 80's of the last century. Nowadays, specific treatment of PAH can be realized by the huge number of substances that are currently available. Still, the time point of starting an intravenous medication is not defined yet. By evaluation of data concerning risk strata of PAH patients, this issue may be enlightened properly.
Previously collected data concerning risk-adapted therapy in PAH-patient have shown that the mortality is little in the "low-risk-status" patients, only. Thus, all efforts must be undertaken to define the patients in this functional class. For most patients this means a combined therapy of available substances according to well defined procedures. Patients whose status remain as "intermediate-risk-status" after receiving a dual therapy over 3-6 months shall undergo a subsequent triple therapy including Selexipag. However, this therapy may not lead to an improvement of the risk-status or even worsened. In these cases, a subcutaneous or intravenous therapy with prostanoids is indicated.
Currently, there are no data available for those patients treated with at least three months with Selexipag as part of a triple therapy that undergo a subsequent intravenous therapy with Treprostinil if there is no change in their risk-status. In the planned study LPS-II, patients are specifically selected on being treated in a dual therapy and having a stagnating intermediate-risk status. These patients receive an implantation of the medical pump LENUS pro, that enables a permanent infusion of Treprostinil.
The aim of this study is to examine, whether patients can reach an improvement in their intermediate-risk-status after six months of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •diagnosis of pulmonary arterial hypertension (WHO group I) accordingly to international guidelines
- •intermediate or high risk-profile of PAH after at least three months treatment with vasoactive substances including Selexipag
- •indication of intravenous therapy with Treprostinil
- •informed consent given for implantation of the medical pump LENUS pro
- •informed consent given for participation in the LPS-II study
排除标准
- •contraindications according to package information leaflet (LENUS pro) and/or summary of product characteristics (Treprostinil)
- •Patient is diagnosed with PAH with an etiology different from that of the inclusion criteria
- •chronic kidney insufficiency (estimated GFR < 30)
- •hepatic insufficiency: CHILD C (known information from patients medical records)
- •intake of substances with potential for infections: intravenous drug abuse, prednisolone, azathioprine, cyclophosphamide
- •suffering from diseases with potential for infections: immunodeficiency syndrome, diabetes mellitus, diabetic gangrene
- •pregnant or breastfeeding women
- •women of childbearing potential who are not on a reliable and safe form of contraception
结局指标
主要结局
Recovery of clinical stability criteria
时间窗: Baseline and after 6 months intravenous therapy with Treprostinil
to achieve "low-risk-status"
次要结局
- Quality of Life(Baseline and after 6 months intravenous therapy with Treprostinil)
- Polysomnography(Baseline and after 6 months intravenous therapy with Treprostinil)
- Restrictions caused by the implant(immediately after implantation until 6 months intravenous therapy with Treprostinil)