Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 9
- 主要终点
- Time to all-cause death
研究概览
简要总结
The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age
- •Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
- •Fluent in written and spoken English
排除标准
- •Optimized or nearly optimized on evidence-based medical therapies for HF as determined by local investigator
- •Current pregnancy
- •Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
- •eGFR of <20 mL/min/1.73m2 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
- •History of prior heart transplant or currently listed for heart transplant
- •Current left ventricular assist device or planned left ventricular assist device in the next 6 months
- •Currently receiving hospice care
- •Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel
- •Terminal illness other than HF with a life expectancy of <1 year as determined by the enrolling clinician-investigator
研究组 & 干预措施
Experimental: Remote Virtual Cardiology Program
The Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions.
干预措施: Remote Virtual Cardiology Program (Other)
Usual Care
Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site.
结局指标
主要结局
Time to all-cause death
时间窗: Up to 120 days
Number of participants with worsening Heart Failure events
时间窗: Up to 120 days
Time to first worsening Heart Failure event
时间窗: Up to 120 days
Change in the number of classes of Heart Failure medications
时间窗: Up to 120 days
次要结局
- Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure)(Baseline, 120 days)
- Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure)(Baseline, 120 days)
- Change in the number of classes of HF (heart failure) medications(Baseline, 120 days)
- Composite of all-cause death and total worsening HF (heart failure) events defined by hospitalizations for acute decompensated HF and other urgent medical care for worsening HF(30 day, 60 day, 120 day)
- Number of participants with combined Emergency department visits and hospitalizations(30 day, 60 day, 120 day)