Heart FailurePhase 1/2NCT00738517
Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
A Phase 1/2 study testing Immunoadsorption / Immunoglobulin substitution in people with Heart Failure and Coronary Heart Disease, 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 cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Heart Disease
- What is being tested?
- Immunoadsorption / Immunoglobulin substitution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Dec 2011
- 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
- heart failure and known coronary heart disease / post myocardial infarction
- completed treatment for coronary heart disease (no known hemodynamically effective stenosis in coronary vessels)
- evidence of scarred myocardial tissue in low-dose stress echocardiography or myocardial scintigraphy or MRI
- evidence of hypo-contractile myocardium in echocardiography or MRI outside of infarction area
- at least 3 months without acute coronary syndrome or coronary intervention
- left-ventricular ejection fraction by echocardiography < 45%
Show all 9Show fewer
- detection of at least one myocardial autoantibody (e.g. anti-ß1-receptor, anti-TnI, anti-KchIP2) in serum
- dyspnea on exertion equivalent to NYHA II - NYHA IV
- written informed consent of the patient
Who cannot join
- heart failure due to other cardiac disease (e.g. dilatative cardiomyopathy without evidence of CHD, primary valve defects > II°, toxic cardiomyopathy)
- 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, Mecklenburg-Vorpommern, 17475
About this study
Official title: Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction
The purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.
Read the detailed description
Heart failure due to coronary heart disease (CHD) remains one of the most frequent causes of death. Left-ventricular ejection fraction < 30% is associated with a 5-year mortality > 70%. Therefore, new strategies and therapies towards treatment of heart failure are needed.
Heart failure due to left ventricular dysfunction can develop in CHD beyond the area of myocardial infarction. Some of these patients develop myocardial autoantibodies, which have been shown to exert a negative inotropic effect. Their elimination by immunoadsorption has been shown to improve left ventricular function in dilatative cardiomyopathy. Immunoglobulins are substituted to minimize infection risk at a level, which has been shown not to effect cardiac function. This intervention might also ameliorate cardiac function in patients with heart failure due to other origins. This study therefore aims to evaluate the effect of immunoadsorption with subsequent immunoglobulin substitution.
- Conditions
- Heart Failure, Coronary Heart Disease
- Being tested
- Immunoadsorption / Immunoglobulin substitution
- Keywords
- heart failure, coronary heart disease, autoantibodies, immunoadsorption, immunoglobulin substitution
- Medical subject headings
- Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorption / Immunoglobulin substitutionDevice
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 |
|---|---|---|
| 1 | Active comparator | Immunoadsorption with subsequent immunoglobulin substitution Receives: Device: Immunoadsorption / Immunoglobulin substitution |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
left-ventricular ejection fraction as measured by echocardiography
Measured: 6 months
Secondary outcomes (6)
cardiac index
Measured: 6 months
systemic vascular resistance
Measured: 6 months
pulmonary vascular resistance
Measured: 6 months
n-terminal pro-BNP concentration (serum)
Measured: 6 months
peak oxygen uptake (spiroergometric)
Measured: 6 months
dyspnoea symptoms / NYHA classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: PI left center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Collaborators
- Fresenius Medical Care North America
- Investigators
- Stephan B Felix, MD, Study chair, University Medicine GreifswaldLars R Herda, MD, Study director, University Medicine GreifswaldAstrid Hummel, MD, Principal investigator, University Medicine GreifswaldMarcus Doerr, MD, Principal investigator, University Medicine GreifswaldDaniel Beug, MD, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738517
- Sponsor's protocol ID
- MPG 01/08
- Status last verified
- May 2016
- First submitted
- 18 Aug 2008
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649.
PubMed 9950662Okazaki T, Tanaka Y, Nishio R, Mitsuiye T, Mizoguchi A, Wang J, Ishida M, Hiai H, Matsumori A, Minato N, Honjo T. Autoantibodies against cardiac troponin I are responsible for dilated cardiomyopathy in PD-1-deficient mice. Nat Med. 2003 Dec;9(12):1477-83. doi: 10.1038/nm955. Epub 2003 Nov 2.
PubMed 14595408Dorffel WV, Felix SB, Wallukat G, Brehme S, Bestvater K, Hofmann T, Kleber FX, Baumann G, Reinke P. Short-term hemodynamic effects of immunoadsorption in dilated cardiomyopathy. Circulation. 1997 Apr 15;95(8):1994-7. doi: 10.1161/01.cir.95.8.1994.
PubMed 9133505Felix SB, Staudt A, Dorffel WV, Stangl V, Merkel K, Pohl M, Docke WD, Morgera S, Neumayer HH, Wernecke KD, Wallukat G, Stangl K, Baumann G. Hemodynamic effects of immunoadsorption and subsequent immunoglobulin substitution in dilated cardiomyopathy: three-month results from a randomized study. J Am Coll Cardiol. 2000 May;35(6):1590-8. doi: 10.1016/s0735-1097(00)00568-4.
PubMed 10807465Staudt A, Schaper F, Stangl V, Plagemann A, Bohm M, Merkel K, Wallukat G, Wernecke KD, Stangl K, Baumann G, Felix SB. Immunohistological changes in dilated cardiomyopathy induced by immunoadsorption therapy and subsequent immunoglobulin substitution. Circulation. 2001 Jun 5;103(22):2681-6. doi: 10.1161/01.cir.103.22.2681.
PubMed 11390337
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00738517
- Acronym / sponsor ID
- MPG 01/08
- Conditions
- Heart Failure, Coronary Heart Disease
- Keywords
- heart failure, coronary heart disease, autoantibodies, immunoadsorption, immunoglobulin substitution
- 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
- Collaborators
- Fresenius Medical Care North America
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Aug 2008 (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 cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.
Detailed description
Heart failure due to coronary heart disease (CHD) remains one of the most frequent causes of death. Left-ventricular ejection fraction < 30% is associated with a 5-year mortality > 70%. Therefore, new strategies and therapies towards treatment of heart failure are needed.
Heart failure due to left ventricular dysfunction can develop in CHD beyond the area of myocardial infarction. Some of these patients develop myocardial autoantibodies, which have been shown to exert a negative inotropic effect. Their elimination by immunoadsorption has been shown to improve left ventricular function in dilatative cardiomyopathy. Immunoglobulins are substituted to minimize infection risk at a level, which has been shown not to effect cardiac function. This intervention might also ameliorate cardiac function in patients with heart failure due to other origins. This study therefore aims to evaluate the effect of immunoadsorption with subsequent immunoglobulin substitution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Immunoadsorption / Immunoglobulin substitutionImmunoadsorption with subsequent immunoglobulin substitution |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- heart failure and known coronary heart disease / post myocardial infarction
- completed treatment for coronary heart disease (no known hemodynamically effective stenosis in coronary vessels)
- evidence of scarred myocardial tissue in low-dose stress echocardiography or myocardial scintigraphy or MRI
- evidence of hypo-contractile myocardium in echocardiography or MRI outside of infarction area
- at least 3 months without acute coronary syndrome or coronary intervention
Key exclusion criteria (6 listed)
- heart failure due to other cardiac disease (e.g. dilatative cardiomyopathy without evidence of CHD, primary valve defects > II°, toxic cardiomyopathy)
- active infection
- pregnancy
- malign tumor disease
- other secondary disease with life expectancy < 1 year
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 / Immunoglobulin substitutionAlso: ImmunosorbaImmunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight) | Device | 1 |
Primary outcome
left-ventricular ejection fraction as measured by echocardiography
Time frame: 6 months
6 secondary outcomes
cardiac index
Time frame: 6 months
systemic vascular resistance
Time frame: 6 months
pulmonary vascular resistance
Time frame: 6 months
n-terminal pro-BNP concentration (serum)
Time frame: 6 months
peak oxygen uptake (spiroergometric)
Time frame: 6 months
dyspnoea symptoms / NYHA classification
Time frame: 6 months
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 11 May 2016.
- Background: PubMed 9950662Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649.
- Background: PubMed 14595408Okazaki T, Tanaka Y, Nishio R, Mitsuiye T, Mizoguchi A, Wang J, Ishida M, Hiai H, Matsumori A, Minato N, Honjo T. Autoantibodies against cardiac troponin I are responsible for dilated cardiomyopathy in PD-1-deficient mice. Nat Med. 2003 Dec;9(12):1477-83. doi: 10.1038/nm955. Epub 2003 Nov 2.
- Background: PubMed 9133505Dorffel WV, Felix SB, Wallukat G, Brehme S, Bestvater K, Hofmann T, Kleber FX, Baumann G, Reinke P. Short-term hemodynamic effects of immunoadsorption in dilated cardiomyopathy. Circulation. 1997 Apr 15;95(8):1994-7. doi: 10.1161/01.cir.95.8.1994.
- Background: PubMed 10807465Felix SB, Staudt A, Dorffel WV, Stangl V, Merkel K, Pohl M, Docke WD, Morgera S, Neumayer HH, Wernecke KD, Wallukat G, Stangl K, Baumann G. Hemodynamic effects of immunoadsorption and subsequent immunoglobulin substitution in dilated cardiomyopathy: three-month results from a randomized study. J Am Coll Cardiol. 2000 May;35(6):1590-8. doi: 10.1016/s0735-1097(00)00568-4.
- Background: PubMed 11390337Staudt A, Schaper F, Stangl V, Plagemann A, Bohm M, Merkel K, Wallukat G, Wernecke KD, Stangl K, Baumann G, Felix SB. Immunohistological changes in dilated cardiomyopathy induced by immunoadsorption therapy and subsequent immunoglobulin substitution. Circulation. 2001 Jun 5;103(22):2681-6. doi: 10.1161/01.cir.103.22.2681.
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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.
Stephan B Felix, MD study chair
University Medicine Greifswald
Lars R Herda, MD study director
University Medicine Greifswald
Astrid Hummel, 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 / Immunoglobulin substitution in people with Heart Failure and Coronary Heart Disease, 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 9 inclusion and 6 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 11 May 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?
left-ventricular ejection fraction as measured by echocardiography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738517, which also lists 5 linked publications.
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 11 May 2016.