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Immunoadsorption in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01126411
Recruitment Status : Withdrawn (PI left center)
First Posted : May 19, 2010
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Marcus Doerr, University Medicine Greifswald

May 12, 2010
May 19, 2010
November 16, 2016
October 2009
December 2013   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01126411 on ClinicalTrials.gov Archive Site
  • 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)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).

  • 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).

  • 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).

Same as current
Not Provided
Not Provided
 
Immunoadsorption in Patients With Pulmonary Hypertension
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Pulmonary Resistance
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
  • No Intervention: control
    control group / no immunoadsorption
  • Active Comparator: immunoadsorption
    immunoadsorption
    Intervention: Procedure: immunoadsorption / immunglobulin substitution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
20
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01126411
IA-2010-001
No
Not Provided
Not Provided
Marcus Doerr, University Medicine Greifswald
University Medicine Greifswald
Not Provided
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
University Medicine Greifswald
November 2016

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