This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary Arterial Hypertension and WHO functional classification III.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
TheraSorb® Treatment with one TheraSorb® Ig flex adsorber pair, used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy. 5 treatments performed over 5 to 8 consecutive days.
Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B
Greifswald, Mecklenburg-Vorpommern, Germany
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin
Cologne, North Rhine-Westphalia, Germany
Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie
Primary endpoint is the change of pulmonary vascular resistance (PVR) at rest before immunoadsorption compared to 3 months after immunoadsorption therapy determined by right heart catheterization (RHC).
Time frame: Baseline, 3 months after therapy
all-cause mortality
The patients will be followed for the duration of the study participation, an expected average of 6 months.
Time frame: ~6months
occurrence and number of Adverse Events
The patients will be followed for the duration of the study participation, an expected average of 6 months.
Time frame: ~6 months
Six-minute walk test (6MWT)
Time frame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Quality of life questionnaires
SF-36 EQ-5D™
Time frame: Measurements at baseline, and after ~1 month, ~3 months, ~6 months
WHO functional classification
WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification
Time frame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP
(Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output, cardiac index, venous oxygen saturation, systolic pulmonary arterial pressure.)
Time frame: Measurements at baseline, after ~3 months
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Berlin, Germany
Reduction of IgG
Time frame: Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment