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NCT02380534 Clinical Trial

Use of Apheretic Technologies in Cardiovascular Disease

Dyslipidemia Clinical Trial

Official title:
Use of H.E.L.P. Apheresis in Patients With High Cardiovascular Disease Lp(a)-Related

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02380534
Other study ID # P-20140023880
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information
Verified date May 2022
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some inflammatory adypocytokines in patients with high cardiovascular risk.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date February 4, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - high Lp(a) not responsive to diet and pharmacological treatment Exclusion Criteria: - heart failure - hepatic failure - renal failure

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• H.E.L.P. apheresis
High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.

Locations
Country Name City State
Italy IRCCS Policlinico S. Matteo Pavia

Sponsors (2)
Lead Sponsor Collaborator
University of Pavia IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other Lipid profile We will evaluate the efficacy of apheretic technique through the reduction of total cholesterol, LDL and HDL cholesterol, and triglycerides in the plasma sample expressed by mg/dL. 1 year
Primary Lp(a) reduction We will evaluate the efficacy of apheretic technique through the reduction of Lp(a) in the plasma sample expressed by mg/dL. 1 year
Secondary Inflammatory adypocytokines We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample. 1 year
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