Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Quality of life/symptom score
研究概览
简要总结
This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.
详细描述
The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be unaware of their group assignment. Investigators delivering the intervention vs. sham will be aware. Analysts processing primary data (serum testing, echocardiographic dimensions, 6-min walk distance, CPEX) will not be aware of group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Ischemic Cardiomyopathy
- •Ejection Fraction </= 35% despite at least 3 months stable standard medical management
- •New York Heart Association Class II-III symptoms
- •Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
- •Normal Atrioventricular conduction or Biventricular ICD
- •QRS < 120 msec (inherent conduction or paced with BiV ICD)
- •Exclusion criteria:
- •Age < 18 years
- •Inability to ambulate safely
- •Congenital or primary valve disease
- •Left Ventricular thrombus
- •Severe peripheral arterial disease
- •Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
- •Major surgery in the past 3 months or anticipated during the period of the trial
- •Paced or intrinsic QRS >120 msec
- •Life expectancy < 1 year
- •Hemodialysis
- •Hematocrit < 30%
- •Severe Chronic lung disease
- •Pregnancy
- •ICD battery longevity < 1 year
- •Unsuppressed atrial arrhythmias
- •Already participating in an exercise programusion Criteria
排除标准
- 未提供
结局指标
主要结局
Quality of life/symptom score
时间窗: 4 weeks after start of the protocol
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
次要结局
- six minute walk(at the time of enrollment, and at 4 weeks after start of the protocol)
- diastolic blood pressure(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- systolic blood pressure(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- MACE(4 weeks and 4 months after start of the protocol)
- Oxygen saturation(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- cardiac output(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
研究者
Denise Hodgson-Zingman
Professor
University of Iowa