Cardiovascular Diseases, Dyslipidemias, Hypercholesterolemia, Familial
Conditions
Keywords
Lipoprotein apheresis
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.
Interventions
DEVICELipoprotein Apheresis MONET and DALI
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
DEVICELipoprotein Apheresis DIAMED and DALI
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicentric, open, interventional, cross-over with randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Removal rate of total cholesterol | every week for 6 weeks or biweekly for 12 weeks | Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems |
| Removal rate of low density lipoprotein cholesterol (LDL-C) | every week for 6 weeks or biweekly for 12 weeks | Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems |
| Removal rate of triglycerides | every week for 6 weeks or biweekly for 12 weeks | Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems |
| Removal rate of lipoprotein (a) (Lp(a)). | every week for 6 weeks or biweekly for 12 weeks | Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems |
Countries
Germany
Outcome results
None listed