Use of Apheretic Technologies in Cardiovascular Disease

Not Applicable

Withdrawn

• Conditions: Dyslipidemia
• Interventions: Procedure: H.E.L.P. apheresis

• Registration Number: NCT02380534
• Lead Sponsor: University of Pavia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-05
• Primary Completion: 2016-02-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-21
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• high Lp(a) not responsive to diet and pharmacological treatment

Exclusion Criteria

• heart failure
• hepatic failure
• renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active procedure	H.E.L.P. apheresis	High cardiovascular risk patients will undergo H.E.L.P. apheresis.

Primary Outcome Measures

Name	Time	Method
Lp(a) reduction	1 year	We will evaluate the efficacy of apheretic technique through the reduction of Lp(a) in the plasma sample expressed by mg/dL.

Secondary Outcome Measures

Name	Time	Method
Inflammatory adypocytokines	1 year	We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.

Trial Locations

Locations (1)

IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy