Immunoadsorption in Patients With Pulmonary Hypertension

November 15, 2016 updated by: Marcus Doerr, University Medicine Greifswald

Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Greifswald, MV, Germany, 17489
        • Ernst Moritz Arndt Universität Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
control group / no immunoadsorption
ACTIVE_COMPARATOR: 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 Names:
  • immunosorba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary vascular Resistance
Time Frame: 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).
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
echocardiographic parameters: TAPSE
Time Frame: 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)
3 month
NYHA
Time Frame: 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).
3 month
nt pro BNP
Time Frame: 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).
3 month
peak oxygen uptake (spiroergometry)
Time Frame: 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).
3 month
6 min walktest
Time Frame: 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).
3 month
ET-1 TYP A Receptor Autoantibody level
Time Frame: 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).
3 month
echocardiographic parameters: PAPs
Time Frame: 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).
3 month
electrocardiographic parameters: S´lat. TR Annulus
Time Frame: 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).
3 month
echocardiographic parameters: AT right ventricular outflow
Time Frame: 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).
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Study Director: Ralf Ewert, Prof, University Medicine Greifswald
  • Principal Investigator: Markus Reinthaler, MD, University Medicine Greifswald
  • Principal Investigator: Lars R Herda, MD, University Medicine Greifswald
  • Study Chair: Stephan B Felix, Prof., University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (ESTIMATE)

May 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA-2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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