Treating Congestive Heart Failure Using a Device to Remove Cholesterol

January 12, 2016 updated by: Patrick Moriarty, MD, FACP, FACC

LDL Apheresis for the Treatment of Congestive Heart Failure

A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure.

Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who qualify for the study will receive 7 bi-weekly LDL-Apheresis treatments with the Kaneka Liposorber device. Patients will assess their CHF symptoms using the KC Cardiomyopathy questionnaire prior to each treatment. Blood levels of certain indices related to CHF and safety profile labs will be drawn before and after the first and last treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female, between the age of 18 and 85 years old. If female, must guarantee that pregnancy will not occur for duration of study
  • Presence of Left ventricular systolic dysfunction due to ischemic or non-ischemic cardiomyopathy and have symptoms of New York Heart Association Class III chronic Heart failure (CHF)
  • Left ventricular ejection fraction (LVEF) ≤ 35% as measured by radionuclide angiography
  • Subject must be on optimal conventional heart failure therapy including Beta-blocker in target or maximally tolerated doses for at least 3 months prior to entry into the study, and/or an angiotension receptor blocker (ARB) for at least 30 days prior to study entry. Subjects on ACE inhibitors, with approval of their physician, have been switched to an ARB one week before initiating apheresis
  • Other optimal conventional therapy have been taken for at least 30 days prior to initiation of apheresis
  • Subject is able to complete the 6-minute walk test and the Kansas City Congestive Heart Failure Quality of Life Questionnaire (KCCQ)
  • Not currently in, or planning to participate in other studies

Exclusion Criteria:

  • Age <18 years, or >85 years of age
  • Poor venous access
  • CHF due to, or associated with, uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, or primary pulmonary hypertension
  • Subject has undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within six months prior to initiation of apheresis treatment
  • Subject is listed for transplantation and is expected to be transplanted within 6 months of initiation of apheresis treatment
  • Subject has had a myocardial infarction within 6 months prior to initiation of apheresis treatment
  • Subject with electrocardiogram (ECG) recorded at initial screening showing particular abnormalities
  • Subject has sustained VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter replacement, or by an electrophysiology procedure, or addressed by placement of an automatic implantable cardiac defibrillator (AICD)
  • Subject has an AICD that has fired for any ventricular arrhythmia within 90 days of the initial visit
  • Subject has unstable angina
  • Subject on a mechanical assist device
  • Subject has evidence of concomitant disease that may interfere with the natural course of the subjects underlying heart failure for the duration of the study
  • Subject has poorly controlled diabetes mellitus
  • Subject is currently taking study prohibited medication
  • Subject is unable to tolerate Beta blocker therapy or asthma, has a heart rate of <55 bpm, or the presence of second or third degree heart block without an implanted pacemaker, and first-degree heart block with a PR interval > 220 milliseconds
  • Subject has active disease, that in the opinion of the Investigator, may adversely affect the safety and efficacy of the treatment or the life span of the patient
  • Subject has history of, or is currently abusing alcohol or illicit drugs
  • Subject has serum potassium <4.0 mEq/L or >5.5mEq/L at initial visit
  • Subject has serum digoxin level of >1.2ng/mL at time of initial visit
  • Subject is pregnant or at risk of becoming pregnant during study
  • Subject is currently lactating
  • Subject has participated in a clinical drug or device trial in the last 90 days
  • Subject has demonstrated noncompliance with previous medical regimens
  • Subject is currently hospitalized, and is not hemodynamically stable, or has an acute cardiac or non-cardiac illness that requires further hospitalization
  • Subject is unable, or unwilling to change from an ACEI to an ARB
  • Subject has a known hypersensitivity to heparin or ethylene oxide
  • Subject has a known Low-density lipoprotein cholesterol (LDL-C) level of >130mg/dl

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Device: Kaneka Liposorber
LDL-apheresis on a bi-weekly basis
Other Names:
  • Liposorber LA-15 System (Kaneka, Osaka, Japan)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Improved Symptoms score on KCCQ
Time Frame: 3 Months
3 Months
Improved Ejection Fraction on ECHO
Time Frame: 3 Months
3 Months
Improved distance during 6-minute walk test
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity
Time Frame: Approximately 2 hours, 3 months apart
Approximately 2 hours, 3 months apart

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Patrick Moriarty, MD, FACP, FACC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kaneka Medical America LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Moriarty, M.D., University of Kansas Medical Center

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

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10282

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.

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