Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02889315
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2016-08-31
Brief Title:
LenusPro Pump in PAH Treated With Treprostinil
Sponsor:
Department of Pulmonary Circulation and Thromboembolic Diseases Medical Center for Postgraduate Med
Organization:
Department of Pulmonary Circulation and Thromboembolic Diseases Medical Center for Postgraduate Med
Study Overview
Official Title:
Assessment of Safety and Efficacy of Implantable Pump LenusPro in Patients With Pulmonary Arterial Hypertension Treated With Treprostinil
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subcutaneous treprostinil is used to treat pulmonary arterial hypertension PAH Due to local pain it causes a deterioration of quality of life or even abandonment of treatment The aim of this study was to evaluate the safety and quality of life QoL in patients treated with treprostinil administration using an implantable Lenus Pro pump This is a observational study involving patients with PAH treated with a subcutaneous infusion of treprostinil with intolerable pain at the infusion site who were therefore referred for pump implantation Clinical evaluation including QoL assessment with SF-36 questionnaire was performed at the time of initiating therapy with treprostinil before and 2-9 months after implantation
Detailed Description:
Treprostinil is a prostacyclin analogue a drug that is widely used to treat pulmonary arterial hypertension PAH Its efficacy was confirmed in studies that compared it to placebo and to epoprostenol Due to stability of treprostinil sodium solution and its relatively long when compared to prostacyclin half-life the drug enabled PAH patients to receive safe long-term treatment It is administered as a continuous subcutaneous infusion using an insulin pump In the case of this route of administration its half-life is about 3 hours Unfortunately due to reaction at the infusion site many patients report significant deterioration of quality of life and some of them about 5-10 even abandon treatment There are trials in progress to find a more convenient method of administration for this drug The efficacy of oral administration has been uncertain - reports are contradictory while inhalations remain a valid alternative for patients in a less advanced stage of the disease Therefore for patients whose illness is more severe only continuous parenteral administration of the drug remains an option
The Lenus Pro implantable pump appears to be a promising alternative to an external pump By means of this method treprostinil sodium is administered as a continuous intravenous infusion and the drug reservoir is refilled every 28 days Thermal stability of treprostinil at body temperature was confirmed during a 60-day observation concentrations of the drug administered intravenously are comparable to subcutaneous administration and the only differing parameter is a shorter half-life of less than 1 hour The first experiences with implantable pumps originate in Austria and Germany and present this method of treatment as a milestone in PAH therapy In Poland the first implantation of a Lenus Pro pump took place in 2013 18
The aim of this study is an analysis of efficacy and safety of treatment with intravenous treprostinil administered by means of the Lenus Pro implantable pump
Prior to pump implantation the subcutaneous dose of treprostinil is escalated up to the highest dose tolerated by a particular patient The procedure of pump implantation is carried out under general anaesthesia Clinical and haemodynamic evaluation is performed at the time of initiating PAH therapy with treprostinil Right before and during 2-9 months after Lenus Pro pump implantation non-invasive clinical evaluation was made including WHO functional class 6-minute walking test 6MWT and concentration of NT-proBNP Additionally patients fill in the SF36 quality of life questionnaire before implantation and 2-9 months after implantation
The Lenus Pro implantable pump appears to be a promising alternative to an external pump By means of this method treprostinil sodium is administered as a continuous intravenous infusion and the drug reservoir is refilled every 28 days Thermal stability of treprostinil at body temperature was confirmed during a 60-day observation concentrations of the drug administered intravenously are comparable to subcutaneous administration and the only differing parameter is a shorter half-life of less than 1 hour The first experiences with implantable pumps originate in Austria and Germany and present this method of treatment as a milestone in PAH therapy In Poland the first implantation of a Lenus Pro pump took place in 2013 18
The aim of this study is an analysis of efficacy and safety of treatment with intravenous treprostinil administered by means of the Lenus Pro implantable pump
Prior to pump implantation the subcutaneous dose of treprostinil is escalated up to the highest dose tolerated by a particular patient The procedure of pump implantation is carried out under general anaesthesia Clinical and haemodynamic evaluation is performed at the time of initiating PAH therapy with treprostinil Right before and during 2-9 months after Lenus Pro pump implantation non-invasive clinical evaluation was made including WHO functional class 6-minute walking test 6MWT and concentration of NT-proBNP Additionally patients fill in the SF36 quality of life questionnaire before implantation and 2-9 months after implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None