Lipoprotein Types--Lp System Lp(A) HyperlipoproteinemiaMultiSELECtNCT02791802
Effect of Lipoprotein(a) Elimination by Lipoprotein Apheresis on Cardiovascular Outcomes
An observational study of Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, run by Technische Universität Dresden at 12 sites in Germany.
Trial summary
This multicenter multinational prospective two-arm matched-pair observational study aims to establish a prospective comparison of active lipoprotein apheresis treatment approved and conducted according to German guidelines for the indication of elevated Lp(a) versus a maximum tolerated lipid-lowering therapy as… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
- How many people
- 1,000 participants
- Where
- 12 sitesGermany
- Study dates
- Aug 2016to Dec 2022
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants have to be 18 years or older and need to be intellectually capable to understand and follow the study protocol. All subjects have to present with progressive cardiovascular disease and need to fulfill the criteria fixed in the recommendations by the German Joint Federal Committee (in German: "Gemeinsamer Bundesausschuss"; see section 1.2). In addition, a TEC has to verify presence of the treatment indication and will be blinded with respect to subject's group assignment. Apheresis subjects (group A) will be included in chronological order, since this will most likely reflect the natural distribution of disease in the general population. Control subjects (group B) will then be matched to the lipoprotein apheresis subjects entering the study.
Who may be able to join
- Age 18 - 70
- Male or female
- Written informed consent
- Lipoprotein(a) > 60 mg/dL, or > 120 nmol/L using an alternative laboratory method
- Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment.
- Established cardiovascular disease with disease progression indicated by one major cardiovascular event, which might be either
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- myocardial infarction
- PCI
- CABG
- Stroke
- or revascularization of peripheral arteries using PTA, stenting or bypass surgery
- (with or without subsequent cardiovascular events/interventions) despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment
- (Hypertension, Diabetes, tobacco consumption, LDL Cholesterol)
- Platelet aggregation inhibitors or systemic anticoagulation according to cardiologic indication
- Positive recommendation by central Trial Expert Committee
Who cannot join
- Previous lipoprotein apheresis therapy
- Triglyceride concentrations ≥ 250 mg/dL (2.8 mmol/L)
- Known homozygous or compound heterozygous familial hypercholesterolemia
- Known type III hyperlipoproteinemia
- Pregnancy, breast feeding
- Active smoking, defined as any inhaled tobacco consumption with in the last 3 months
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- Uncontrolled hypertension (>160/90 mmHg)
- Active malignant disease
- Planned major surgical procedures
- Current participation in an interventional trial
- Contraindication for apheresis therapy (e. g. necessity of ACE inhibitor therapy)
- CKD stages IV and V
- Diabetes mellitus
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Klinik für Kardiologie
Bad Oeynhausen, 32545
Klaus Peter Mellwig, MD
- Recruiting
Dialyse am Kortumpark
Bochum, 44789
Velthof Ansgar, MD
- Recruiting
University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
Ulrich Julius, MD, +493514582176, ulrich.julius@ukdd.de
- Recruiting
Nephrologisches Zentrum Göttingen
Göttingen, 37075
Volker Schettler, MD
- Recruiting
PHV Dialysezentrum
Meißen, 01662
Beate Schulze, MD
- Recruiting
Klinikum der Universität München Campus Innenstadt
München, 80337
Anja Vogt, MD
- Recruiting
Klinikum der Universität München Campus Großhadern
München, 81337
Klaus Parhofer, MD
- Recruiting
Dialysezentrum Potsdam
Potsdam, 14471
Jens Ringel, MD
- Recruiting
Nierenzentrum Reinbek
Reinbek, 21465
Markus Reinbek, MD
- Recruiting
Nephrocare Rostock GmbH Medizinisches Versorgungszentrum Südstadt
Rostock, 18059
Wolfgang Ramlow, MD
- Recruiting
Nephrologisches Zentrum
Villingen-Schwenningen, 78052
Bernd Hohenstein, MD
hohenstein@nephrologie-vs.de
- Recruiting
Heinrich Braun Klinikum
Zwickau, 08060
Jens Gerth, MD
About this study
Official title: A European Multicenter Study on the Effect of Lipoprotein(a) Elimination by Lipoprotein Apheresis on Cardiovascular Outcomes
This multicenter multinational prospective two-arm matched-pair observational study aims to establish a prospective comparison of active lipoprotein apheresis treatment approved and conducted according to German guidelines for the indication of elevated Lp(a) versus a maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character and the inclusion of a control arm, this will be the first clinical study that can confirm the relevance of the established approach to use lipoprotein apheresis in those subjects and its effects to reduce the individual cardiovascular risk. The optimized management of subjects in the control group (not receiving lipoprotein apheresis) will also help to clarify the controversial issue, to which extent intensive medical care per se can influence the occurence of subsequent cardiovascular events. Primary objective of the trial is to evaluate the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial infarction, PCI, CABG, fatal and non- fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries and death from cardiovascular disease. The primary objective of this study evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with progressive cardiovascular disease, as accepted by the German Federal Joint Committee as indication for subjects with elevated Lp(a). Comparator will be matched subjects under maximum tolerated lipid lowering therapy without access to lipoprotein apheresis treatment. The clinical benefit will be defined as the reduction of the composite endpoint of major adverse cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack or death from cardiovascular disease over a period of at least 2 years after completion of visit 1b and until at least 60 events of the primary end-point occurred in group B. If the number of at least 60 documented primary endpoint events within 2 years of the completion of enrolment did not occur, the study will continue until this number of primary endpoint events has accumulated.
- Keywords
- Lipoprotein(a), lipoprotein/lipid apheresis, CV disease
- Medical subject headings
- Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Lipoprotein apheresis subjects | Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. Additional lipoprotein apheresis is established following enrolment using the following established systems: Dextran-sulfate adsorption (DSA) from plasma and whole blood, Heparin-induced LDL precipitation apheresis (HELP®), Polyacrylate adsorption from whole blood and simple DFPP (DALI® and Monet®), ApoB100-immunoadsorption (TheraSorbLDL®, Temperature-optimized double filtration plasmapheresis (DFPP). | |
| Group B: Control group | Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. The control group will not undergo a sham apheresis procedure. It is an open trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point is an at least 10 % reduction of the proportion of events
The primary end-point is an at least 10 % reduction of the proportion of events regarding the composite end-point consisting either of myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries or death from cardiovascular disease (or any combination of these) at the final visit.
Measured: 2 years of follow-up
Secondary outcomes (3)
An at least 10 % reduction of the proportion of events
An at least 10 % reduction of the proportion of events regarding the composite endpoint of cardiovascular death, major coronary event, cerebrovascular accidents and stroke.
Measured: 2 years of follow-up
An at least 10 % reduction of the proportion of events
An at least 10 % reduction of the proportion of events regarding the composite endpoint of cardiovascular death, major coronary events and all cerebrovascular events.
Measured: 2 years of follow-up
An at least 10 % reduction of the proportion of events regarding the composite Secondary endpoints of the Trial
An at least 10 % reduction of the proportion of events regarding the composite endpoint of CV death, non-fatal MI, documented unstable angina that requires admission into a hospital, all revascularization (including both coronary and non-coronary) occurring at least 30 days after the MACE event, the rate of in-stent restenosis and non-fatal stroke.
Measured: 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein Types--Lp System Lp(A) HyperlipoproteinemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Pharma Europe N.V.
- Responsible party
- Principal investigator, Prof. Bernd Hohenstein, Technische Universität Dresden
- Investigators
- Bernd Hohenstein, MD, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791802
- Sponsor's protocol ID
- TUD-LPA16-001
- Acronym
- MultiSELECt
- Status last verified
- Apr 2022
- First submitted
- 26 May 2016
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Multicenter Study on the Effect of Lipoprotein(a) Elimination by Lipoprotein Apheresis on Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT02791802
- Acronym / sponsor ID
- MultiSELECt / TUD-LPA16-001
- Keywords
- Lipoprotein(a), lipoprotein/lipid apheresis, CV disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Kaneka Pharma Europe N.V.
- Study start
- Aug 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Jun 2016 (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.
This multicenter multinational prospective two-arm matched-pair observational study aims to establish a prospective comparison of active lipoprotein apheresis treatment approved and conducted according to German guidelines for the indication of elevated Lp(a) versus a maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character and the inclusion of a control arm, this will be the first clinical study that can confirm the relevance of the established approach to use lipoprotein apheresis in those subjects and its effects to reduce the individual cardiovascular risk. The optimized management of subjects in the control group (not receiving lipoprotein apheresis) will also help to clarify the controversial issue, to which extent intensive medical care per se can influence the occurence of subsequent cardiovascular events. Primary objective of the trial is to evaluate the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial infarction, PCI, CABG, fatal and non- fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries and death from cardiovascular disease. The primary objective of this study evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with progressive cardiovascular disease, as accepted by the German Federal Joint Committee as indication for subjects with elevated Lp(a). Comparator will be matched subjects under maximum tolerated lipid lowering therapy without access to lipoprotein apheresis treatment. The clinical benefit will be defined as the reduction of the composite endpoint of major adverse cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack or death from cardiovascular disease over a period of at least 2 years after completion of visit 1b and until at least 60 events of the primary end-point occurred in group B. If the number of at least 60 documented primary endpoint events within 2 years of the completion of enrolment did not occur, the study will continue until this number of primary endpoint events has accumulated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Lipoprotein apheresis subjects | – | –Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. Additional lipoprotein apheresis is established following enrolment using the following established systems: Dextran-sulfate adsorption (DSA) from plasma and whole blood, Heparin-induced LDL precipitation apheresis (HELP®), Polyacrylate adsorption from whole blood and simple DFPP (DALI® and Monet®), ApoB100-immunoadsorption (TheraSorbLDL®, Temperature-optimized double filtration plasmapheresis (DFPP). |
| Group B: Control group | – | –Established cardiovascular disease with disease progression indicated by one major cardiovascular event. With or without subsequent cardiovascular events/interventions, despite adequately controlled cardiovascular risk factors occuring within the last 2 years prior to enrolment. Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment. The control group will not undergo a sham apheresis procedure. It is an open trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants have to be 18 years or older and need to be intellectually capable to understand and follow the study protocol. All subjects have to present with progressive cardiovascular disease and need to fulfill the criteria fixed in the recommendations by the German Joint Federal Committee (in German: "Gemeinsamer Bundesausschuss"; see section 1.2). In addition, a TEC has to verify presence of the treatment indication and will be blinded with respect to subject's group assignment. Apheresis subjects (group A) will be included in chronological order, since this will most likely reflect the natural distribution of disease in the general population. Control subjects (group B) will then be matched to the lipoprotein apheresis subjects entering the study.
Key inclusion criteria (15 listed)
- Age 18 - 70
- Male or female
- Written informed consent
- Lipoprotein(a) > 60 mg/dL, or > 120 nmol/L using an alternative laboratory method
- Corrected Low-density lipoprotein cholesterol < 100 mg/dL (2.6 mmol/l) during 3 months prior to study enrolment.
Key exclusion criteria (13 listed)
- Previous lipoprotein apheresis therapy
- Triglyceride concentrations ≥ 250 mg/dL (2.8 mmol/L)
- Known homozygous or compound heterozygous familial hypercholesterolemia
- Known type III hyperlipoproteinemia
- Pregnancy, breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary end-point is an at least 10 % reduction of the proportion of events
Time frame: 2 years of follow-up
The primary end-point is an at least 10 % reduction of the proportion of events regarding the composite end-point consisting either of myocardial infarction, PCI, CABG, fatal and non-fatal stroke, transient ischemic attack, interventional or surgical revascularization of peripheral arteries or death from cardiovascular disease (or any combination of these) at the final visit.
3 secondary outcomes
An at least 10 % reduction of the proportion of events
Time frame: 2 years of follow-up
An at least 10 % reduction of the proportion of events
Time frame: 2 years of follow-up
An at least 10 % reduction of the proportion of events regarding the composite Secondary endpoints of the Trial
Time frame: 2 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Study HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Bernd Hohenstein, MD principal investigator
Technische Universität Dresden
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, run by Technische Universität Dresden at 12 sites 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 15 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Kaul (+49 351 458 ext. 3075, info@multiselect-trial.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point is an at least 10 % reduction of the proportion of events (time frame: 2 years of follow-up). 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 2 May 2022.