Integrated Diagnostics Can Alter Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 13
- 主要终点
- Change in subject self-care utilizing the Self-Care of Heart Failure Index
研究概览
简要总结
The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. This system consists of patient tools, a new heart failure risk score and a new clinician website. This study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Subject is willing and able to provide written informed consent
- •Subject is at least 18 years of age
- •Subject is willing and able to comply with the Clinical Investigation Plan
- •Subject is currently enrolled in the Medtronic CareLink® Network
- •Subject is currently a New Heart Association (NYHA) functional class III or NYHA functional class II with a heart failure related hospitalization within the past 180 days
- •Subject has a Medtronic Concerto®/Consulta® cardiac resynchronization therapy (CRT)device implanted for at least 180 days
- •Subject has been prescribed daily oral diuretic therapy for the management of heart failure
排除标准
- •Subject is enrolled in a concurrent study with the exception of a study approved by the INDICATE HF Clinical Trial Leader
- •Subject has a life expectancy of less than 1 year
- •Subject's CRT device has an estimated battery life of less than 2 years
结局指标
主要结局
Change in subject self-care utilizing the Self-Care of Heart Failure Index
时间窗: Baseline, 3 months, 6 months, 9 months
Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website)
时间窗: Baseline to 9 months
Number of clinical actions and types of health care utilizations in which actions are initiated
时间窗: Baseline to 9 months
Subject outcomes including emergency room (ER) visits, hospitalization and death
时间窗: Baseline to 9 months
Functional class using measurements including 6-minute hall walk and New York Heart Association class
时间窗: Hall walk (Baseline to 9 months), NYHA (Baseline, 3 months, 6 months, 9 months)
Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire
时间窗: Baseline, 3 months, 6 months, 9 months
次要结局
未报告次要终点