Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI

Cardiovascular Diseases Clinical Trial

— DIAMOND-2018  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795038
• Other study ID #: TA-DMD-01-D
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: May 25, 2021

Study information

• Verified date: July 2022
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias
• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II

Intervention

Device:
• Lipoprotein Apheresis MONET and DALI
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
• Lipoprotein Apheresis DIAMED and DALI
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Dresden	Sachsen
Germany	Nephrocare Rostock GmbH	Rostock	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal rate of total cholesterol	Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems	every week for 6 weeks or biweekly for 12 weeks
Primary	Removal rate of low density lipoprotein cholesterol (LDL-C)	Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems	every week for 6 weeks or biweekly for 12 weeks
Primary	Removal rate of triglycerides	Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems	every week for 6 weeks or biweekly for 12 weeks
Primary	Removal rate of lipoprotein (a) (Lp(a)).	Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems	every week for 6 weeks or biweekly for 12 weeks