Trial document





This trial has been registered retrospectively.
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  DRKS00003119

Trial Description

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Title

Prospective documentation: isolated Lp(a)-hyperlipoproteinemia with progressive cardiovascular disease and treatment with lipid apheresis

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Trial Acronym

Pro(a)-LiFe

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Lipid apheresis is a method for extracorporeal blood purification to eliminate certain harmful lipid components from human blood. This method is in clinical routine since many years for patients with severe disorders of lipid metabolism to decrease the so called LDL-cholesterol in blood.
Since 2008, lipid apheresis is in Germany also approved for regular reimbursement by health insurances for a rare disorder of lipid metabolism, the isolated elevation of the blood lipid lipoprotein(a) (Lp(a)). The increase of Lp(a) in combination with a progressive cardiovascular disease can potentially be life-threatening. The amount of Lp(a) is mainly hereditary. Lipid apheresis is the only therapeutic option to effectively decrease the amount of Lp(a) in blood. In general, patients have to be treated once a week.
Together with the approval for regular reimbursement, the German federal joint committee (G-BA), as responsible authority, demanded to prove efficacy of lipid apheresis for patients with elevated Lp(a) by collecting scientific data.
Aim of the Pro(a)-LiFe project is to document clinical data of patients who are treated with lipid apheresis for their elevated Lp(a) since the G-BA approval in 2008 and to analyze the benefit for the patients. The individual course of disease during the first two years after commencing lipid apheresis will be compared with the course of disease during the last two years before apheresis. Performance and tolerability of selected treatments will be documented regularly for quality control.

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Brief Summary in Scientific Language

Lipid apheresis for isolated Lp(a)-hyperlipoproteinemia (Lp(a)-HLP) with progressive cardiovascular disease has been approved for regular reimbursement in Germany by the federal joint committee (G-BA) in 2008. G-BA recognized that for high-risk patients with life-threatening disease lipid apheresis must be considered as the only therapeutic option. Due to a shortage of clinical data the G-BA in parallel demanded to prove efficacy preferentially by conducting a prospective controlled clinical trial. The beginning of this study is uncertain.
Aim of the Pro(a)-LiFe project is to document all patients with isolated Lp(a)-HLP treated since 2008 with lipid apheresis. Prospectively collected data on the individual disease course during the first two years after commencing lipid apheresis will be compared with the disease course during the last two years before apheresis. With this concept, the time between the G-BA approval and the start of the controlled study can be used to minimize the gap in documentation of clinical data. The Pro(a)-LiFe is a project throughout Germany with the aim to document and analyze at least 120 patients with isolated Lp(a) who are treated with lipid apheresis according to the 2008 reimbursement criteria of the G-BA.
In general, patients were routinely treated ambulatory once a week as part of their standard medical care. Before beginning with lipid apheresis, a committee of the association of statutory health insurance physicians has checked and approved in each individual case the indication for lipid apheresis according to the G-BA guideline (www.g-ba.de).
Safety and tolerability of lipid apheresis will be analyzed by evaluation of selected treatments. In Germany, several CE-marked lipid apheresis methods are commercially available. The lipid apheresis method which is used for the treatment of the individual patient is chosen at the discretion of the treating physician.
Patients gave their written informed consent before start of the documentation.

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Organizational Data

  •   DRKS00003119
  •   2011/06/29
  •   [---]*
  •   yes
  •   Approved
  •   011/1504, Freiburger Ethik-Kommission International
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E78 -  Disorders of lipoprotein metabolism and other lipidaemias
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Interventions/Observational Groups

  •   All patients are treated with lipid apheresis as part of their standard medical care. Lipid apheresis treatments are performed with an in Germany commercially available CE-marked lipid apheresis system which fulfills the quality criteria of the G-BA guideline. The lipid apheresis system is chosen at the discretion of the physician for the individual patient. Depending on the Lp(a) concentration, lipid apheresis treatments are performed once a week or biweekly.

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Comparison of prospectively documented cardiovascular events within the first 2 years after commencing lipid apheresis with retrospectively recorded cardiovascular events within the two years before lipid apheresis.

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Secondary Outcome

Documentation of safety and tolerability of lipid apheresis by analyzing the performance of single treatments at the beginning and every 6 months. Documentation of health related quality of life before and during apheresis treatments by using the SF36 questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/03/05
  •   170
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Indication for lipid apheresis because of isolated Lp(a)-HLP over 60 mg/dl and LDL-cholesterol within the normal range as well as a progressive cardiovascular disease which is clinically and by imaging techniques documented. The competent association of statutory health insurance physicians has checked and approved the indication for lipid apheresis, the health insurance has confirmed reimbursement.
Patient is routinely treated with lipid apheresis. Patient has signed informed consent.

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Exclusion Criteria

Patient doesn’t agree to participate.
Treating physician doesn’t want to participate.

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Addresses

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    • Apherese Forschungsinstitut
    • Stadtwaldgürtel 77
    • 50935  Köln
    • Germany
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    • Apherese Forschungsinstitut
    • Mr.  Prof. Dr. med.  Reinhard  Klingel 
    • Stadtwaldgürtel 77
    • 50935  Köln
    • Germany
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    • Apherese Forschungsinstitut
    • Mr.  Prof. Dr. med.  Reinhard  Klingel 
    • Stadtwaldgürtel 77
    • 50935  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Diamed Medizintechnik GmbH
    • Stadtwaldgürtel 77
    • 50935   Köln
    • Germany
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    •   +49 221 940 5000
    •   +49 221 940 500 11
    •   diamed at diamed.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/08/25
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* This entry means the parameter is not applicable or has not been set.