Immunoadsorption in Patients With Pulmonary Hypertension
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate, if Immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve haemodynamics in patients with pulmonary hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension Pulmonary Resistance |
Procedure: immunoadsorption / immunglobulin substitution |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension |
- pulmonary vascular Resistance [ Time Frame: 3 month ] [ Designated as safety issue: No ]The extend of change of pulmonary vascular resistance over the observation period will be compared between the 2 groups (treatment versus control group).
- echocardiographic parameters: TAPSE [ Time Frame: 3 month ] [ Designated as safety issue: No ]TAPSE=excursion of the lateral tricuspid annulus (measured in m-mode). the extend of cange of TAPSE over the observationperiod will be compared between the 2 groups (treatment vs. controlgroup)
- NYHA [ Time Frame: 3 month ] [ Designated as safety issue: No ]NYHA = functional capacity. The extent of change of NYHA-class over the observation period will be compared between the 2 groups (treatment versus control group).
- nt pro BNP [ Time Frame: 3 month ] [ Designated as safety issue: No ]nt pro BNP = B-type natriuretic peptide. The extent of change of nt-pro BNP over the observation period will be compared between the 2 groups (treatment versus control group).
- peak oxygen uptake (spiroergometry) [ Time Frame: 3 month ] [ Designated as safety issue: No ]The extent of change of peak oxygen uptake over the observation period will be compared between the 2 groups (treatment versus control group).
- 6 min walktest [ Time Frame: 3 month ] [ Designated as safety issue: No ]The extent of change of 6-min walktest over the observation period will be compared between the 2 groups (treatment versus control group).
- ET-1 TYP A Receptor Autoantibody level [ Time Frame: 3 month ] [ Designated as safety issue: No ]The extent of change of ET-1 TYP A Receptor Autoantibody level over the observation period will be compared between the 2 groups (treatment versus control group).
- echocardiographic parameters: PAPs [ Time Frame: 3 month ] [ Designated as safety issue: No ]
PAPs = systolic pulmonalarterial pressure estimated by maximal flow velocity of tricuspid regurgitant jet (continues doppler).
The extent of change of PAPs over the observation period will be compared between the 2 groups (treatment versus control group).
- electrocardiographic parameters: S´lat. TR Annulus [ Time Frame: 3 month ] [ Designated as safety issue: No ]
S´lat. TR Annulus = systolic velocity of the lateral tricuspid annulus measured by tissue doppler.
The extent of change of S´ lat. TR Annulus over the observation period will be compared between the 2 groups (treatment versus control group).
- echocardiographic parameters: AT right ventricular outflow [ Time Frame: 3 month ] [ Designated as safety issue: No ]
AT right ventricular outflow = acceleration time of right ventricular outflow, measured by pulsed wave doppler echocardiography.
The extent of change of AT over the observation period will be compared between the 2 groups (treatment versus control group).
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
control group / no immunoadsorption
|
|
|
Active Comparator: immunoadsorption
immunoadsorption
|
Procedure: immunoadsorption / immunglobulin substitution
Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)
Other Name: immunosorba
|
Detailed Description:
Increased pulmonary precapillary vascular resistance due to vasoconstriction and vasoproliferative processes is the basic pathophysiological mechanism in the development of pulmonary hypertension (PH). In patients with pulmonary arterial hypertension (PH) production of endothelin-1 (ET-1) is increased and elevated ET-1 plasma levels correlate with PH severity As recently shown Autoantibodies against the Endothelin-1 Typ A and Angiotensin II Typ-1 Receptor, which have a high Incidence in PH-Patients, may also play an important role in the pathophysiology of PH (Dandel et al.).
The concept of this study is that the elimination of these autoantibodies by Immunoadsorption with protein A may improve haemodynamics and patient wellbeing. Immunoglobulins are substituted after Immunoadsorption to minimize infection risk.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pulmonary hypertension (PH)
- NYHA II-IV
- medical treatment of PH respective to current guidelines
- 18 years or older
- written informed consent of the patient
Exclusion Criteria:
- pulmonary hypertension due to left ventricular dysfunction
- decompensated heart failure
- need for Catecholamines
- active infection
- pregnancy
- malign tumor disease
- other secondary disease with life expectancy < 1 year
- refusal by the patient
Contacts and Locations| Contact: Stephan B Felix, Prof. | +493834866656 | felix@uni-greifswald.de |
| Contact: Markus B Reinthaler, MD | +433834866656 | markus.reinthaler@gmx.at |
| Germany | |
| Ernst Moritz Arndt Universität Greifswald | Recruiting |
| Greifswald, MV, Germany, 17489 | |
| Contact: Stephan B Felix, Prof. +433834866656 felix@uni-greifswald.de | |
| Contact: Markus Reinthaler, MD +433834866607 markus.reinthaler@gmx.at | |
| Study Director: | Ralf Ewert, Prof | Ernst-Moritz-Arndt-Universität Greifswald |
| Principal Investigator: | Markus Reinthaler, MD | Ernst-Moritz-Arndt-Universität Greifswald |
| Principal Investigator: | Lars R Herda, MD | Ernst-Moritz-Arndt-Universität Greifswald |
| Study Chair: | Stephan B Felix, Prof. | Ernst Moritz Arndt Universität Greifswald |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Dr. med. Stephan B. Felix, Ernst Moritz Arndt University of Greifswald |
| ClinicalTrials.gov Identifier: | NCT01126411 History of Changes |
| Other Study ID Numbers: | IA-2010-001 |
| Study First Received: | May 12, 2010 |
| Last Updated: | May 18, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Medicine Greifswald:
|
pulmonary hypertension autoantibodies immunoadsorption immunoglobulin substitution right ventricular function |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013