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Immunoadsorption in Patients With Pulmonary Hypertension

NCT ID: NCT01126411

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Hypertension Pulmonary Resistance

Keywords

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pulmonary hypertension autoantibodies immunoadsorption immunoglobulin substitution right ventricular function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

control group / no immunoadsorption

Group Type NO_INTERVENTION

No interventions assigned to this group

immunoadsorption

immunoadsorption

Group Type ACTIVE_COMPARATOR

immunoadsorption / immunglobulin substitution

Intervention Type PROCEDURE

Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)

Interventions

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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)

Intervention Type PROCEDURE

Other Intervention Names

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immunosorba

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Marcus Doerr

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Ewert, Prof

Role: STUDY_DIRECTOR

University Medicine Greifswald

Markus Reinthaler, MD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Lars R Herda, MD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Stephan B Felix, Prof.

Role: STUDY_CHAIR

University Medicine Greifswald

Locations

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Ernst Moritz Arndt Universität Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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IA-2010-001

Identifier Type: -

Identifier Source: org_study_id