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
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Pulmonary Resistance
Procedure: immunoadsorption / immunglobulin substitution
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).



Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
control group / no immunoadsorption
Active Comparator: 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)
Other Name: immunosorba

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126411

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

Locations
Germany
Ernst Moritz Arndt Universität Greifswald Recruiting
Greifswald, MV, Germany, 17489
Contact: Stephan B Felix, Prof.    +433834866656    felix@uni-greifswald.de   
Contact: Markus Reinthaler, MD    +433834866607    markus.reinthaler@gmx.at   
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. Stephan B. Felix, Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier: NCT01126411     History of Changes
Other Study ID Numbers: IA-2010-001
Study First Received: May 12, 2010
Last Updated: May 18, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
pulmonary hypertension
autoantibodies
immunoadsorption
immunoglobulin substitution
right ventricular function

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 28, 2014