Immunoadsorption in Patients With Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University Medicine Greifswald.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Medicine Greifswald

ClinicalTrials.gov Identifier:

NCT01126411

First received: May 12, 2010

Last updated: May 18, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 12, 2010

Last Updated Date

May 18, 2010

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01126411 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immunoadsorption in Patients With Pulmonary Hypertension

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Hypertension
Pulmonary Resistance

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: control
control group / no immunoadsorption
Active Comparator: immunoadsorption
immunoadsorption

Intervention: Procedure: immunoadsorption / immunglobulin substitution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stephan B Felix, Prof.	+493834866656	felix@uni-greifswald.de
Contact: Markus B Reinthaler, MD	+433834866656	markus.reinthaler@gmx.at

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01126411

Other Study ID Numbers ^ICMJE

IA-2010-001

Has Data Monitoring Committee

Responsible Party

Prof. Dr. med. Stephan B. Felix, Ernst Moritz Arndt University of Greifswald

Study Sponsor ^ICMJE

University Medicine Greifswald

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University Medicine Greifswald

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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