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LenusPro Pump in PAH Treated With Treprostinil

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ClinicalTrials.gov Identifier: NCT02889315
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Marcin Kurzyna, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

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.

Condition or disease
Pulmonary Arterial Hypertension

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Safety and Efficacy of Implantable Pump (LenusPro) in Patients With Pulmonary Arterial Hypertension Treated With Treprostinil.
Study Start Date : November 2013
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : December 2018





Primary Outcome Measures :
  1. Safety of transition from subcutaneous delivery do intravenous delivery through LenusPro pump [ Time Frame: from implantation to 6 months thereafter ]
  2. Improvement of QoL caused by changing therapy measured with SF-36 form [ Time Frame: from implantation to 6 months thereafter ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary arterial hypertension treated with treprostinil in subcutaneous infusion with severe local side effects
Criteria

Inclusion Criteria:

  • diagnosed with Pulmonary Arterial Hypertnesion according to ESC/ERS Guidelines
  • treatment with sc treprostinil at stable dose
  • poor local tolerance of sc infusion

Exclusion Criteria:

  • life expectancy < 6 months
  • age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889315


Contacts
Contact: Marcin Kurzyna, MD,PhD +48-22-7103052 marcin.kurzyna@ecz-otwock.pl
Contact: Paulina Bąbik, MCS +48-22-7103052 paulina.babik@ecz-otwock.pl

Locations
Poland
European Health Center Otwock Recruiting
Otwock, Poland, 05-400
Contact: Marcin Kurzyna, MD,PhD    +48-22-7103052    marcin.kurzyna@ecz-otwock.pl   
Sponsors and Collaborators
Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

Responsible Party: Marcin Kurzyna, Marcin Kurzyna, MD, PhD, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
ClinicalTrials.gov Identifier: NCT02889315     History of Changes
Other Study ID Numbers: 001
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marcin Kurzyna, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med:
PAH
treprostinil
LenusPro
implantable device
quality of life

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents