NCT04292275终止不适用
A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 18
- 试验地点
- 16
- 主要终点
- Time to Change or Decision That Heart Failure Therapy is Optimal
研究概览
简要总结
A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chronic heart failure.
- •Ejection fraction equal to or below 40%.
- •New York Heart Association (NYHA) class II to class III.
- •Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.
排除标准
- •Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney).
- •Currently in an investigational device or drug study.
- •Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.
结局指标
主要结局
Time to Change or Decision That Heart Failure Therapy is Optimal
时间窗: Randomization to 6 months
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy.
次要结局
- Time to change or decision that heart failure therapy is optimal(Baseline to 6 months)
- Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)(Week 24)
- Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores(Baseline and Week 24)
- Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores(Week 24)
- Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy(Baseline and Week 24)
研究者
研究点 (16)
Loading locations...
相似试验
Unknown
不适用
Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial FibrillationAtrial FibrillationNCT04306978Research Institute for Complex Problems of Cardiovascular Diseases, Russia200
招募中
不适用
The HEARTFELT StudyHeart FailureHeart FailureChronic Heart FailureNCT06222099Heartfelt Technologies1,500
尚未招募
不适用
Investigating the acceptability of remotely monitoring the vital signs of hospital-in-the-home patients using wearable devices, from the perspective of the patients, clinicians and administrators.ACTRN12623000018617Silver Chain Group Limited30
招募中
不适用
Remote Assessment of Signs and Symptoms in Palliative CarePalliative CareVital SignsRemote MonitoringNCT06587321Our Lady's Hospice and Care Services30
已完成
不适用
Assessing Tele-Health Outcomes in Multiyear Extensions of PD TrialsParkinson DiseaseNCT03538262Massachusetts General Hospital226