HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Hospitalizations
研究概览
简要总结
The goal of this trial is to determine if the addition of the Heart Logic diagnostic alerts to standard of care therapies will lessen hospitalizations and improve quality of life in patients with heart failure.
详细描述
Investigator-sponsored post-market, randomized, multicenter trial evaluating the HeartLogic diagnostic in optimizing GDMT in patients with chronically low EF
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age 18 years or older
- •EF </=35%
- •Prior hospitalization within the last two years or prior decompensation to NYHA class III or IV over the last 12 months that was treated without hospitalization
- •HeartLogic capable ICD or CRT-D (Patients with HeartLogic capable ICD or CRT-D can be enrolled at time of de novo implantation or generator change out or at the time of the 2 week wound check. Prior Heart logic capable ICF or CRT-D implants can be enrolled if heart failure hospitalization shows decompensation within six months (prior implants must have at least 1 year battery life)
排除标准
- •Refuse to give consent
- •Have Life expectancy of less than one-year
- •Documented noncompliance that limits medication use
- •Patients on Dialysis (renal insufficiency but not on dialysis is NOT an exclusion)
- •Pregnancy
研究组 & 干预措施
Active Treatment Arm
Heart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT
干预措施: Heartlogic Diagnostic Tool Threshold Change (Device)
Control Arm
Heart Logic transmission of 16 or greater may be reported to the appropriate device clinic staff by Latitude transmission and then referred to the appropriate treating provider. Medication changes will be based upon physician preference/standards. Repeat transmissions, follow-up, laboratory studies will be per physician preference.
干预措施: Heartlogic Diagnostic Tool Unchanged Threshold (Device)
结局指标
主要结局
Hospitalizations
时间窗: 365 Days
Number of Hospitalizations
次要结局
- Number of ICD Shocks(365 Days)
- nt-ProBNP(365 days)
研究者
Robert Pickett
MD
Ascension Health