Clinical trial NCT01126411: Immunoadsorption in Patients With Pulmonary Hypertension
Official title: Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Pulmonary Hypertension
Pulmonary Resistance
Keywords: pulmonary hypertension
autoantibodies
immunoadsorption
immunoglobulin substitution
right ventricular function
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pulmonary vascular Resistance
timeFrame: 3 month
Secondary outcomes:
measure: echocardiographic parameters: TAPSE
timeFrame: 3 month
measure: NYHA
timeFrame: 3 month
measure: nt pro BNP
timeFrame: 3 month
measure: peak oxygen uptake (spiroergometry)
timeFrame: 3 month
measure: 6 min walktest
timeFrame: 3 month
measure: ET-1 TYP A Receptor Autoantibody level
timeFrame: 3 month
measure: echocardiographic parameters: PAPs
timeFrame: 3 month
measure: electrocardiographic parameters: S´lat. TR Annulus
timeFrame: 3 month
measure: echocardiographic parameters: AT right ventricular outflow
timeFrame: 3 month
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt Universität Greifswald
state: MV
Study officials:
affiliation: University Medicine Greifswald
name: Ralf Ewert, Prof
role: STUDY_DIRECTOR
affiliation: University Medicine Greifswald
name: Markus Reinthaler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Lars R Herda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Stephan B Felix, Prof.
role: STUDY_CHAIR
References: