Immunoadsorption in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01126411
• Other study ID #: IA-2010-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 12, 2010
• Last updated: November 15, 2016
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Pulmonary Resistance

Intervention

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)

Locations

Country	Name	City	State
Germany	Ernst Moritz Arndt Universität Greifswald	Greifswald	MV

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary vascular Resistance	The extend of change of pulmonary vascular resistance over the observation period will be compared between the 2 groups (treatment versus control group).	3 month	No
Secondary	echocardiographic parameters: TAPSE	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)	3 month	No
Secondary	NYHA	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).	3 month	No
Secondary	nt pro BNP	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).	3 month	No
Secondary	peak oxygen uptake (spiroergometry)	The extent of change of peak oxygen uptake over the observation period will be compared between the 2 groups (treatment versus control group).	3 month	No
Secondary	6 min walktest	The extent of change of 6-min walktest over the observation period will be compared between the 2 groups (treatment versus control group).	3 month	No
Secondary	ET-1 TYP A Receptor Autoantibody level	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).	3 month	No
Secondary	echocardiographic parameters: PAPs	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).	3 month	No
Secondary	electrocardiographic parameters: S´lat. TR Annulus	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).	3 month	No
Secondary	echocardiographic parameters: AT right ventricular outflow	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).	3 month	No