Remote Monitoring To Identify Worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- Primary Composite Outcome
研究概览
简要总结
Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life.
The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure.
Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values.
详细描述
Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made.
For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place.
Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows:
- All-Cause Mortality
- Hospital Admission for Heart Failure
- Hospital Visit for Worsening Heart Failure
- Ventricular Arrhythmias
- Atrial Arrhythmias
Additionally, the study will explore the association between physical activity measured by the devices and these specified events.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will not know whether the algorithms was activated or not at the beginning of the study. However, if a contact with the patient is made due to the algorithm, the patient will then understand they are not on the control group.
The person responsible for contacts will also know if an individual patient is on the control or intervention group.
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
- •Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms.
- •Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%.
排除标准
- •Younger than 18 years old or older than 85 years old.
- •Unable to be contacted when out of the hospital.
- •Presence of severe cognitive impairment.
- •Currently on the heart transplant waiting list
结局指标
主要结局
Primary Composite Outcome
时间窗: 2 years
All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area.
次要结局
- All-cause mortality(2 years)
- Worsening Heart failure(2 eras)
- Hospital admission for Heart Failure(2 years)
- Ventricular Arrhythmias(2 years)
- Atrial Arrhytmias(2 years)
研究者
Goncalo Terleira Batista
Cardiology Resident
Unidade Local de Saúde de Coimbra, EPE