Heart Failure Optimization Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 602
- 试验地点
- 64
- 主要终点
- Percentage of Patients With LVEF Recovery at Day 90 and 180
研究概览
简要总结
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.
详细描述
This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Phase 1 (Registry phase)
- •Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days.
- •Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times).
- •Phase 2 (Study phase)
- •Patients who completed Phase 1 and used a WCD for 90 ± 14 days.
- •Exclusion Criteria (both phases):
- •Patients under 18 years old.
- •Patients who have an active unipolar pacemaker.
- •Patients with a physical or mental condition that could impair their ability to properly interact with the device.
- •Patients currently participating in another clinical study.
- •Patients with any skin condition that would prevent wearing the device.
- •Patients with an advanced directive prohibiting resuscitation.
- •Exclusion criteria (Phase 2)
- •Patients who have a QRS duration of ≥135 ms and are planned for cardiac resynchronization therapy.
- •Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
排除标准
- 未提供
结局指标
主要结局
Percentage of Patients With LVEF Recovery at Day 90 and 180
时间窗: 180 days
The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
时间窗: 180 days
Descriptive statistics will be used to assess the percentage of study subjects reaching target doses of GDMT at 90 and 180 days. All eligible study subjects with LVEF data at all three timepoints were used for this analysis.
次要结局
- All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use(360 days)
- All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use(360 days)
- Percentage of All Patients Having Other Arrhythmias(180 days)
- Efficacy in Treating Ventricular Arrhythmias(180 days)
- Healthcare utilization_type(360 days)
- Mortality Analysis(0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months))
- Healthcare utilization_length of Use(360 days)