Clinical trial NCT03795038: Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
Official title: Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI: Cross-over Study in Patients With Cardiovascular Disease and Severe Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia, Familial
Dyslipidemias
Cardiovascular Diseases
Keywords: Lipoprotein apheresis
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, multicentric, open, interventional, cross-over with randomization
Primary purpose: TREATMENT

Brief summary: The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.

Detailed description: Comparison of the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.

The primary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)).

The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in removing other novel efficacy parameters.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorised physician
* Minimum age of 18 years
* Ability to understand the nature and requirements of the study

Study-specific inclusion criteria:

* Patients with indication for lipoprotein apheresis confirmed by a local apheresis expert commission according to the German guidelines \[1\] and with routine lipoprotein apheresis treatments for at least 3 months. Patients with weekly treatments have not missed more than 3 treatment sessions within the 3 months prior inclusion to the study. Patients with biweekly treatment sessions have not missed more than 1 treatment session within the 3 months prior inclusion to the study
* Patients with regular weekly or biweekly lipoprotein apheresis treatments with either MONET or DIAMED lipoprotein apheresis systems for at least 4 weeks (weekly treatments) or 8 weeks (biweekly treatments) with the same system
* With adequate venous access
* With systolic blood pressure \> 100 mmHg
* With stable hematocrit \>35 %
* With stable anticoagulation

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study
* Pregnancy or lactation period (pregnancy test will be conducted with female patients aged 55 years)
* Participation in an interventional clinical study during the preceding 30 days or in the same study

Study-specific exclusion criteria:

* Occurrence or clinical relevant deterioration of acute myocardial infarction, unstable angina pectoris, severe hemo-dynamic relevant arrhythmia within 3 months prior inclusion to the study
* Bypass surgery, vascular diseases, active infection (this means chronic infectious diseases (e.g. chronic hepatitis) and acute infections with a core body temperature ≥ 38.0 °C) or unstable circulation (see exclusion criteria no. 7) within the last 3 months
* Uncontrolled high or low blood pressure defined as systolic blood pressure \>180 mmHg/\<100 mmHg and/or diastolic blood pressure \>115 mmHg (after three times measuring)
* Changes in lipid lowering medication within the last 2 weeks
* Intake of Angiotensin Converting Enzyme (ACE) inhibitor medication within a time interval of five times the terminal half-life of the ACE inhibitor before study start and during the study
* History of allergic reactions to anticoagulation

Primary outcomes:
measure: Removal rate of total cholesterol
timeFrame: every week for 6 weeks or biweekly for 12 weeks
measure: Removal rate of low density lipoprotein cholesterol (LDL-C)
timeFrame: every week for 6 weeks or biweekly for 12 weeks
measure: Removal rate of triglycerides
timeFrame: every week for 6 weeks or biweekly for 12 weeks
measure: Removal rate of lipoprotein (a) (Lp(a)).
timeFrame: every week for 6 weeks or biweekly for 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Nephrocare Rostock GmbH
state: Mecklenburg-Vorpommern
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
Study officials:
affiliation: Nephrocare Rostock GmbH
name: Heinrich Prophet, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: