Immunoadsorption in Patients With Pulmonary Hypertension

Phase 1

Withdrawn

• Conditions: Pulmonary Resistance; Pulmonary Hypertension
• Interventions: Procedure: immunoadsorption / immunglobulin substitution

• Registration Number: NCT01126411
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immunoadsorption	immunoadsorption / immunglobulin substitution	immunoadsorption

Primary Outcome Measures

Name	Time	Method
pulmonary vascular Resistance	3 month	The extend of change of pulmonary vascular resistance over the observation period will be compared between the 2 groups (treatment versus control group).

Secondary Outcome Measures

Name	Time	Method
electrocardiographic parameters: S´lat. TR Annulus	3 month	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).
nt pro BNP	3 month	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).
6 min walktest	3 month	The extent of change of 6-min walktest over the observation period will be compared between the 2 groups (treatment versus control group).
peak oxygen uptake (spiroergometry)	3 month	The extent of change of peak oxygen uptake over the observation period will be compared between the 2 groups (treatment versus control group).
ET-1 TYP A Receptor Autoantibody level	3 month	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: TAPSE	3 month	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	3 month	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).
echocardiographic parameters: PAPs	3 month	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).
echocardiographic parameters: AT right ventricular outflow	3 month	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).

Trial Locations

Locations (1)

Ernst Moritz Arndt Universität Greifswald; 🇩🇪 Greifswald, MV, Germany