DyslipidemiaNCT02380534
Use of Apheretic Technologies in Cardiovascular Disease
A study testing H.E.L.P. apheresis in people with Dyslipidemia, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- H.E.L.P. apheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento 4 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high Lp(a) not responsive to diet and pharmacological treatment
Who cannot join
- heart failure
- hepatic failure
- renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dyslipidemia
- Being tested
- H.E.L.P. apheresis
- Keywords
- High level of Lp(a)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.E.L.P. apheresisProcedure or surgery
High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| active procedure | Experimental | High cardiovascular risk patients will undergo H.E.L.P. apheresis. Receives: Procedure: H.E.L.P. apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Inflammatory adypocytokines
We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Primary completion4 Feb 2016
Why it stopped: Funding missing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380534
- Sponsor's protocol ID
- P-20140023880
- Status last verified
- May 2022
- First submitted
- 23 Feb 2015
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of H.E.L.P. Apheresis in Patients With High Cardiovascular Disease Lp(a)-Related
- ClinicalTrials.gov ID
- NCT02380534
- Acronym / sponsor ID
- P-20140023880
- Conditions
- Dyslipidemia
- Keywords
- High level of Lp(a)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding missing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Primary completion
- 4 Feb 2016 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active procedure | Experimental | Procedure: H.E.L.P. apheresisHigh cardiovascular risk patients will undergo H.E.L.P. apheresis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high Lp(a) not responsive to diet and pharmacological treatment
Key exclusion criteria (3 listed)
- heart failure
- hepatic failure
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.E.L.P. apheresisHigh cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year. | Procedure or surgery | active procedure |
Primary outcome
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 secondary outcome
Inflammatory adypocytokines
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.E.L.P. apheresis in people with Dyslipidemia, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lp(a) reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.