Clinical trial NCT00510601: Treating Congestive Heart Failure Using a Device to Remove Cholesterol
Official title: LDL Apheresis for the Treatment of Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Heart Decompensation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Kaneka Medical America LLC
First posted: 2007-08-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved Symptoms score on KCCQ
timeFrame: 3 Months
measure: Improved Ejection Fraction on ECHO
timeFrame: 3 Months
measure: Improved distance during 6-minute walk test
timeFrame: 3 Months
Secondary outcomes:
measure: Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity
timeFrame: Approximately 2 hours, 3 months apart
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patrick Moriarty, M.D.
role: PRINCIPAL_INVESTIGATOR
References: