Pulmonary Arterial Hypertension Clinical Trial
Official title:
LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension
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).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04076241 -
Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension
|
N/A | |
| Completed |
NCT05521113 -
Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
|
||
| Recruiting |
NCT04972656 -
Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension
|
N/A | |
| Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
| Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
| Completed |
NCT01959815 -
Novel Screening Strategies for Scleroderma PAH
|
||
| Recruiting |
NCT04266197 -
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
|
Phase 2 | |
| Active, not recruiting |
NCT06092424 -
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
|
N/A | |
| Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
| Terminated |
NCT02060487 -
Effects of Oral Sildenafil on Mortality in Adults With PAH
|
Phase 4 | |
| Terminated |
NCT02253394 -
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
|
Phase 4 | |
| Withdrawn |
NCT02958358 -
FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan
|
N/A | |
| Terminated |
NCT01953965 -
Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
|
Phase 2 | |
| Not yet recruiting |
NCT01649739 -
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
|
Phase 4 | |
| Unknown status |
NCT01712997 -
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
|
Phase 3 | |
| Withdrawn |
NCT01723371 -
Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
|
Phase 1/Phase 2 | |
| Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01165047 -
Nitric Oxide, GeNO Nitrosyl Delivery System
|
Phase 2 | |
| Completed |
NCT00942708 -
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
|
Phase 2 | |
| Completed |
NCT00963027 -
Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
|
Phase 1 |