Follow-up of Heart Failure Patients with an Implantable Cardiac Defibrillator Enabled with the HeartLogic Algorithm - HeartLogic France Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 10
- 主要终点
- Hospitalisation for heart failure
研究概览
简要总结
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.
The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.
Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L).
If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.
详细描述
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.
The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.
310 patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L).
The HeartLogic index will be monitored remotely on a weekly basis for 12 months and in case of HeartLogic index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. A blind and independent committee will adjudicate the events. Blood samples will be collected for biobanking, and quality of life will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient implanted with a cardiac defibrillator, with or without resynchronization, enabled with the HeartLogic index (RESONATE family, Boston Scientific)
- •History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L)
排除标准
- •Concomitant presence of a heart failure device other than cardiac resynchronisation such as a left ventricular assist device or a device for modulating cardiac contractility.
- •Heart transplant project, or heart transplant patient
- •Glomerular filtration rate <30 ml/mn/m2 or dialysis,
- •Life expectancy ≤ 6 months
- •Remote monitoring of HeartLogic is not possible.
- •Refusal to take medication for heart failure
- •Patient with a mechanical heart valve
结局指标
主要结局
Hospitalisation for heart failure
时间窗: During 12 months
Annual rate of unplanned hospitalisations for heart failure
次要结局
- Cardiovascular mortality(During 12 months)
- Heart failure related mortality(During 12 months)
- Unplanned hospitalisation due to ventricular arrhythmia(During 12 months)
- Unplanned hospitalisations due to atrial arrhythmia(During 12 months)
- Hospitalisation duration related to heart failure, ventricular or atrial arrhythmia(During 12 months)
- Effect of iSGLT2 on HeartLogic index, atrial arrhythmias and ventricular arrhythmias(During 12 months)
- Safety of preemptive congestion treatment based on HeartLogic index(During 12 months)
- Patient quality of life using the Kansas City Cardiomyopathy Questionnaire(At baseline and 1 year)
- Evolution of the average HeartLogic index each week over a 12-month period(During 12 months)