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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5

Phase

  • 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

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
Intervention / Treatment
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

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

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

Patrick Moriarty, MD, FACP, FACC

Collaborators

Kaneka Medical America LLC

Investigators

  • 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

July 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Heart Decompensation

Clinical Trials on Kaneka Liposorber

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe