NCT02380534

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2016

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

First QC Date

February 23, 2015

Last Update Submit

May 21, 2022

Conditions

Dyslipidemia

Keywords

High level of Lp(a)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Inflammatory adypocytokines

    1 year

Other Outcomes (1)

  • Lipid profile

    1 year

Study Arms (1)

active procedure

EXPERIMENTAL

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

Procedure: H.E.L.P. apheresis

Interventions

H.E.L.P. apheresisPROCEDURE

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

active procedure

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • heart failure
  • hepatic failure
  • renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 5, 2015

Primary Completion

February 4, 2016

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

IT(1)