Treating Congestive Heart Failure Using a Device to Remove Cholesterol

NCT00510601 | Completed Early Phase 1

• 1 other identifier: 10282
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Decompensation

Outcome Measures

Primary Outcomes (3)

• Improved Symptoms score on KCCQ

  3 Months

• Improved Ejection Fraction on ECHO

  3 Months

• Improved distance during 6-minute walk test

  3 Months

Secondary Outcomes (1)

• Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity

  Approximately 2 hours, 3 months apart

Study Arms (1)

1

EXPERIMENTAL

Device: Kaneka Liposorber

Interventions

Kaneka Liposorber DEVICE

LDL-apheresis on a bi-weekly basis

Also known as: Liposorber LA-15 System (Kaneka, Osaka, Japan)

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Moriarty, MD, FACP, FACC: lead
• Kaneka Medical America LLC: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Patrick Moriarty, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Pharmacology

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)