Pulmonary Arterial HypertensionNCT02889315
LenusPro Pump in PAH Treated With Treprostinil
An observational study of Pulmonary Arterial Hypertension, run by Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2013to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary arterial hypertension treated with treprostinil in subcutaneous infusion with severe local side effects
Who may be able to join
- diagnosed with Pulmonary Arterial Hypertnesion according to ESC/ERS Guidelines
- treatment with sc treprostinil at stable dose
- poor local tolerance of sc infusion
Who cannot join
- life expectancy < 6 months
- age < 18 years
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
European Health Center Otwock
Otwock, 05-400
Marcin Kurzyna, MD,PhD, +48-22-7103052, marcin.kurzyna@ecz-otwock.pl
About this study
Official title: Assessment of Safety and Efficacy of Implantable Pump (LenusPro) in Patients With Pulmonary Arterial Hypertension Treated With Treprostinil.
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, treprostinil, LenusPro, implantable device, quality of life
- Medical subject headings
- Pulmonary Arterial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of transition from subcutaneous delivery do intravenous delivery through LenusPro pump
Measured: from implantation to 6 months thereafter
Improvement of QoL caused by changing therapy measured with SF-36 form
Measured: from implantation to 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startNov 2013
- Primary completionSep 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Kurzyna, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889315
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Implantable Pump (LenusPro) in Patients With Pulmonary Arterial Hypertension Treated With Treprostinil.
- ClinicalTrials.gov ID
- NCT02889315
- Acronym / sponsor ID
- 001
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, treprostinil, LenusPro, implantable device, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate MedUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension treated with treprostinil in subcutaneous infusion with severe local side effects
Key inclusion criteria (3 listed)
- diagnosed with Pulmonary Arterial Hypertnesion according to ESC/ERS Guidelines
- treatment with sc treprostinil at stable dose
- poor local tolerance of sc infusion
Key exclusion criteria (2 listed)
- life expectancy < 6 months
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of transition from subcutaneous delivery do intravenous delivery through LenusPro pump
Time frame: from implantation to 6 months thereafter
Improvement of QoL caused by changing therapy measured with SF-36 form
Time frame: from implantation to 6 months thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin Kurzyna, MD,PhD (+48-22-7103052, marcin.kurzyna@ecz-otwock.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of transition from subcutaneous delivery do intravenous delivery through LenusPro pump (time frame: from implantation to 6 months thereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.