OptiVol for Precision Medical Management of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care
研究概览
简要总结
This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.
详细描述
Subjects in this study will be randomized (2:1) to an intervention group whose medical care will be guided by data from a cardiac implantable electronic device (CIED) including information on heart rate, activity, and fluid status derived from the OptiVol monitor versus a conventional management control group. Subjects will followed for 12 months with follow up contact for 6 consecutive months and a chart review at 12 months. The study population will include patients with ischemic and non-ischemic cardiomyopathy who have had an ICD implanted per standard of care guidelines.
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
- 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
- •18 to 85 years of age on the date of randomization
- •ICD implantation per guidelines for primary prevention in patients with ischemic and non-ischemic cardiomyopathy ≥3 calendar months ago.
- •SMART Phone or tablet with Bluetooth capability with internet access.
- •No other identifiable reversible cause explaining the left ventricular dysfunction
排除标准
- •CRT implanted
- •LVEF>45% in the last echocardiogram or other clinic imaging study performed.
- •Medtronic device generator and/or device components not implanted
- •Unstable clinical condition, life threatening arrhythmia
- •Heart failure hospitalization within the preceding 3 calendar months
- •Cognitive impairment
- •Severe renal dysfunction (eGFR < 30 ml/min/m2)
- •Serious known concomitant disease with a lift expectancy of < 12 calendar months
- •Non-ambulatory NYHA class IV
- •Pregnancy
结局指标
主要结局
The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care
时间窗: 6 Months
The rate of change as measured in the number of medications modified during medical management with beta-blockers, diuretics and sacubitril/Valsartan (defined as initiation, termination, switch, or dosing adjustment) in the intervention group compared to usual care will serve as the primary outcome. The (minimum, maximum) values (0,5) and the range (0 - 5) apply to the rate of change of the prespecified medications. The greater the rate of change, the more optimization (better) the intervention is altering medical management to personalize the regimen.
次要结局
- Mean Change in Quality of Life Score(6 month)
研究者
Spencer Rosero, MD
Professor Medicine M&D-Cardiology Div
University of Rochester