Pulmonary HypertensionPhase 1/2NCT01126411
Immunoadsorption in Patients With Pulmonary Hypertension
A Phase 1/2 study testing immunoadsorption / immunglobulin substitution in people with Pulmonary Hypertension and Pulmonary Resistance, run by University Medicine Greifswald at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Resistance
- What is being tested?
- immunoadsorption / immunglobulin substitution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pulmonary hypertension (PH)
- NYHA II-IV
- medical treatment of PH respective to current guidelines
- 18 years or older
- written informed consent of the patient
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Ernst Moritz Arndt Universität Greifswald
Greifswald, Mecklenburg-Vorpommern, 17489
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Hypertension, Pulmonary Resistance
- Being tested
- immunoadsorption / immunglobulin substitution
- Keywords
- pulmonary hypertension, autoantibodies, immunoadsorption, immunoglobulin substitution, right ventricular function
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoadsorption / immunglobulin substitutionProcedure or surgery
Also called immunosorba
Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | control group / no immunoadsorption |
| immunoadsorption | Active comparator | immunoadsorption Receives: Procedure: immunoadsorption / immunglobulin substitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 month
Secondary outcomes (9)
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)
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
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).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: PI left center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Doerr, University Medicine Greifswald
- Investigators
- Ralf Ewert, Prof, Study director, University Medicine GreifswaldMarkus Reinthaler, MD, Principal investigator, University Medicine GreifswaldLars R Herda, MD, Principal investigator, University Medicine GreifswaldStephan B Felix, Prof., Study chair, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126411
- Sponsor's protocol ID
- IA-2010-001
- Status last verified
- Nov 2016
- First submitted
- 12 May 2010
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01126411
- Acronym / sponsor ID
- IA-2010-001
- Conditions
- Pulmonary Hypertension, Pulmonary Resistance
- Keywords
- pulmonary hypertension, autoantibodies, immunoadsorption, immunoglobulin substitution, right ventricular function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –control group / no immunoadsorption |
| immunoadsorption | Active comparator | Procedure: immunoadsorption / immunglobulin substitutionimmunoadsorption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pulmonary hypertension (PH)
- NYHA II-IV
- medical treatment of PH respective to current guidelines
- 18 years or older
- written informed consent of the patient
Key exclusion criteria (8 listed)
- pulmonary hypertension due to left ventricular dysfunction
- decompensated heart failure
- need for Catecholamines
- active infection
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunoadsorption / immunglobulin substitutionAlso: immunosorbaImmunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight) | Procedure or surgery | immunoadsorption |
Primary outcome
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).
9 secondary outcomes
echocardiographic parameters: TAPSE
Time frame: 3 month
NYHA
Time frame: 3 month
nt pro BNP
Time frame: 3 month
peak oxygen uptake (spiroergometry)
Time frame: 3 month
6 min walktest
Time frame: 3 month
ET-1 TYP A Receptor Autoantibody level
Time frame: 3 month
echocardiographic parameters: PAPs
Time frame: 3 month
electrocardiographic parameters: S´lat. TR Annulus
Time frame: 3 month
echocardiographic parameters: AT right ventricular outflow
Time frame: 3 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Ewert, Prof study director
University Medicine Greifswald
Markus Reinthaler, MD principal investigator
University Medicine Greifswald
Lars R Herda, MD principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing immunoadsorption / immunglobulin substitution in people with Pulmonary Hypertension and Pulmonary Resistance, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary vascular Resistance (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.