Use of Apheretic Technologies in Cardiovascular Disease

NCT ID: NCT02380534

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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active procedure

High cardiovascular risk patients will undergo H.E.L.P. apheresis.

Group Type EXPERIMENTAL

H.E.L.P. apheresis

Intervention Type PROCEDURE

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

Interventions

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H.E.L.P. apheresis

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* heart failure
* hepatic failure
* renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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P-20140023880

Identifier Type: -

Identifier Source: org_study_id

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