NCT00510601已完成1 期
LDL Apheresis for the Treatment of Congestive Heart Failure
Patrick Moriarty, MD, FACP, FACC1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2007年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improved Ejection Fraction on ECHO
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Experimental
干预措施: Kaneka Liposorber (Device)
结局指标
主要结局
Improved Ejection Fraction on ECHO
时间窗: 3 Months
Improved Symptoms score on KCCQ
时间窗: 3 Months
Improved distance during 6-minute walk test
时间窗: 3 Months
次要结局
- Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity(Approximately 2 hours, 3 months apart)
研究者
Patrick Moriarty, MD, FACP, FACC
Director, Clinical Pharmacology
University of Kansas Medical Center
研究点 (1)
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