NCT05602454已完成不适用
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 14
- 主要终点
- Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
研究概览
简要总结
The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction
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
- •Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF.
- •Access to a smartphone including through a family member of caregiver
- •Fluent in written and spoken English
排除标准
- •Optimized or nearly-optimized on evidence-based medical therapies for HFrEF 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 or ongoing chronic dialysis at screening
- •Prior heart transplant
- •Current or planned left ventricular assist device
- •Currently receiving hospice care
- •Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel
- •Terminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
结局指标
主要结局
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
时间窗: Baseline, 6 months
Scores are 0-3 for 7 key medication classes for heart failure with reduced ejection fraction where 0 represents no use of the medication class
次要结局
- Intensification of evidence-based medical therapies, measured by number of participants with reported changes.(baseline, 6 months)
- Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.(6 months)
- Change in medical therapy, as measured by the Kansas City Medical Optimization score(Baseline, 6 months)
- Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.(6 months)
- Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence(3 months, 6 months)
研究者
研究点 (14)
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