A Phase 1/2 interventional study of immunoadsorption / immunglobulin substitution in Pulmonary Hypertension and Pulmonary Resistance, sponsored by University Medicine Greifswald. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by University Medicine Greifswald · Phase 1/2, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
Browse Hypertension, Pulmonary studies →University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
control group / no 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)
Also known as: immunosorba
pulmonary vascular Resistance
The extend of change of pulmonary vascular resistance over the observation period will be compared between the 2 groups (treatment versus control group).
Time frame: 3 month
echocardiographic parameters: TAPSE
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)
Time frame: 3 month
NYHA
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).
Time frame: 3 month
nt pro BNP
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).
Time frame: 3 month
peak oxygen uptake (spiroergometry)
The extent of change of peak oxygen uptake over the observation period will be compared between the 2 groups (treatment versus control group).
Time frame: 3 month
6 min walktest
The extent of change of 6-min walktest over the observation period will be compared between the 2 groups (treatment versus control group).
Time frame: 3 month
ET-1 TYP A Receptor Autoantibody level
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).
Time frame: 3 month
echocardiographic parameters: PAPs
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).
Time frame: 3 month
electrocardiographic parameters: S´lat. TR Annulus
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).
Time frame: 3 month
echocardiographic parameters: AT right ventricular outflow
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).
Time frame: 3 month
This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald