Multiselect Study
Research type
Research Study
Full title
A European Multicenter Study on the Effect of Lipoprotein(a) Elimination by Lipoprotein Apheresis on Cardiovascular outcomes
IRAS ID
235419
Contact name
Handrean Soran
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 29 days
Research summary
Cardiovascular disease (CVD) is the most common cause of death worldwide. Development of atherosclerotic lesions directly influence the occurrence of most cardiovascular events. LDL-C (low density lipoprotein cholesterol) is a well-established atherosclerotic risk factor that can be improved by lifestyle changes or lipid lowering drugs. Lp(a) (Lipoprotein (a)), a subclass of LDL-C is also a widely accepted independent risk factor for CVD. Lp(a) is genetically determined and cannot be modified by dietic changes or any currently existing medication. Copenhagen Heart study 2008 has shown 15 to 25% of all people have Lp(a) above 30mg/dL which independently increases the risk of CVD. Currently, lipoprotein apheresis is the only therapeutic option to lower Lp(a) levels.
The submitted study compares lipoprotein apheresis treatment (Treatment/Subject Arm A) with maximum tolerated lipid-lowering treatment (Control Arm B) for the indication of elevated Lp(a). This is a prospective, multicentre, multinational, two-arm matched pair cohort study. Arm A is approved and conducted in Germany while there is a lack of approvals for lipoprotein apheresis outside Germany. UK will be taking part only in Arm B. Participation in the control Arm B involves recruiting age, sex and clinically matched patients to Arm A who are on maximum tolerated lipid-lowering therapy as standard care. The patients in Arm B will be followed up for a minimum of 2 years or until at least 60 major adverse cardiovascular events (MACE) occurred in arm B. Arm B involves a screening visit, 6 monthly and yearly follow ups. Study procedures include collection of demographics, previous and current medical history, quality of life questionnaires, physical examination, vital signs, blood and urine sampling.
The study would help to establish Lp(a) as a highly relevant cardiovascular risk factor and justify lipoprotein apheresis treatment in countries not offering this approach for elevated L(a) in patients.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0285
Date of REC Opinion
16 Sep 2019
REC opinion
Further Information Favourable Opinion