ClinicalTrials.Veeva

Menu

Immunoadsorption in Patients With Pulmonary Hypertension

U

University Medicine Greifswald

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Pulmonary Resistance
Pulmonary Hypertension

Treatments

Procedure: immunoadsorption / immunglobulin substitution

Study type

Interventional

Funder types

Other

Identifiers

NCT01126411
IA-2010-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

control
No Intervention group
Description:
control group / no immunoadsorption
immunoadsorption
Active Comparator group
Description:
immunoadsorption
Treatment:
Procedure: immunoadsorption / immunglobulin substitution

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems