Treating Congestive Heart Failure Using a Device to Remove Cholesterol

Heart Decompensation Clinical Trial

Official title:

LDL Apheresis for the Treatment of Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510601
• Other study ID #: 10282
• Status: Completed
• Phase: Phase 0
• First received: July 31, 2007
• Last updated: January 12, 2016
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: January 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure

Intervention

Device:
• Kaneka Liposorber
LDL-apheresis on a bi-weekly basis

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Moriarty, MD, FACP, FACC	Kaneka Pharma America LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Symptoms score on KCCQ		3 Months	Yes
Primary	Improved Ejection Fraction on ECHO		3 Months	Yes
Primary	Improved distance during 6-minute walk test		3 Months	Yes
Secondary	Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity		Approximately 2 hours, 3 months apart	Yes