Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Number of unplanned cardiac care utilization
研究概览
简要总结
The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF).
The main questions the trial aims to answer are:
Does a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits?
Researchers will compare these two groups to a standard care group to see which monitoring approach works best.
Participants will:
Answer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group.
Use a handheld device to take weekly heart readings at home, if they are in the second group.
Follow standard care from their regular doctor without any extra devices, if they are in the third group.
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
- Double (Investigator, Outcomes Assessor)
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
- •Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.
排除标准
- •Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.
- •Documented AF before inclusion
- •Admission to hospices or palliative care
- •Inability to communicate in Dutch or English.
- •Participant is under age of 18 years old
- •Participant is pregnant
- •Mental disorders that, according to the treating physician, make participation unsafe
研究组 & 干预措施
Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder
Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR)
干预措施: Implantable loop recorder (Device)
Arm 2: Patient-driven portable ECG monitoring
Patient-driven portable ECG monitoring
干预措施: Patient-driven portable ECG monitoring (Device)
Arm 3: Usual Care
All patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization.
干预措施: Usual Care (Other)
结局指标
主要结局
Number of unplanned cardiac care utilization
时间窗: 18 months
Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare/day case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.
次要结局
- Quality of life Kansas City Cardiomyopathy Questionnaire(18 months)
- Mortality(18 months)
- Number of planned cardiac care utilization(18 months)
- Time to first diagnosis of AF(18 months)
- The number of participants diagnosed with AF(18 months)
- Pharmaceutical and/or CIED implantation management changes(18 months)
- Number of overall arrhythmia diagnosis(18 months)