Use of Apheretic Technologies in Cardiovascular Disease

May 21, 2022 updated by: Giuseppe Derosa, University of Pavia

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Policlinico S. Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • heart failure
  • hepatic failure
  • renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active procedure
High cardiovascular risk patients will undergo H.E.L.P. apheresis.
Procedure: H.E.L.P. apheresis
High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lp(a) reduction
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory adypocytokines
Time Frame: 1 year
We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

IRCCS Policlinico S. Matteo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 4, 2016

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-20140023880

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on H.E.L.P. apheresis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe