Back to resultsUse of Apheretic Technologies in Cardiovascular Disease
Primary Purpose
Dyslipidemia
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
H.E.L.P. apheresis
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring High level of Lp(a)
Eligibility Criteria
Inclusion Criteria:
- high Lp(a) not responsive to diet and pharmacological treatment
Exclusion Criteria:
- heart failure
- hepatic failure
- renal failure
Sites / Locations
- IRCCS Policlinico S. Matteo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active procedure
Arm Description
High cardiovascular risk patients will undergo H.E.L.P. apheresis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Inflammatory adypocytokines
We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.
Full Information
NCT ID
NCT02380534
First Posted
February 23, 2015
Last Updated
May 21, 2022
Sponsor
University of Pavia
Collaborators
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT02380534
Brief Title
Use of Apheretic Technologies in Cardiovascular Disease
Official Title
Use of H.E.L.P. Apheresis in Patients With High Cardiovascular Disease Lp(a)-Related
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Funding missing
Study Start Date
undefined (undefined)
Primary Completion Date
February 4, 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
Collaborators
IRCCS Policlinico S. Matteo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
High level of Lp(a)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active procedure
Arm Type
Experimental
Arm Description
High cardiovascular risk patients will undergo H.E.L.P. apheresis.
Intervention Type
Procedure
Intervention Name(s)
H.E.L.P. apheresis
Intervention Description
High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.
Primary Outcome Measure Information:
Title
Lp(a) reduction
Description
We will evaluate the efficacy of apheretic technique through the reduction of Lp(a) in the plasma sample expressed by mg/dL.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inflammatory adypocytokines
Description
We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high Lp(a) not responsive to diet and pharmacological treatment
Exclusion Criteria:
heart failure
hepatic failure
renal failure
Facility Information:
Facility Name
IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
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Use of Apheretic Technologies in Cardiovascular Disease
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