A Multi-centre, Prospective, Single-arm, Open-label Trial With a Prespecified Effectiveness Endpoint to Evaluate the Benefits of Haemodynamically Guided Treatment Using the Seerlinq HeartCore System in Heart-failure Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Heart failure hospitalization and mortality
研究概览
简要总结
The goal of this prospective, multicenter, single-arm, open-label clinical trial (Strategy TO Prevent Decompensated Heart Failure) is to evaluate the 6month incidence of heart failure hospitalization (HFH) and all cause mortality in patients managed with haemodynamically guided treatment using the Seerlinq telemedical monitoring system.
详细描述
Study participants will receive the Seerlinq telemedical monitoring system with appropriate training and will perform regular measurements as instructed. HF treatment will be haemodynamically-guided, with clinical decisions informed by trends in LVFP determined by Seerlinq. The primary treatment goal will be to lower elevated LVFP using diuretics, vasodilators, or neurohormonal agents. In addition to LVFP, treatment decisions will be supported by heart rate, patient perceived symptoms (fatigue and shortness of breath) and blood pressure values measured using a certified home blood pressure monitor, enabling more individualized titration of therapy based on a comprehensive haemodynamic profile. In cases where elevated LVFP persists despite treatment adjustments and consultation with a healthcare professional via telephone, or where there is evidence of non-response, patients will be promptly scheduled for an urgent in-person clinical evaluation to assess fluid status, comorbidities, and potential treatment barriers. Furthermore, the Seerlinq-guided approach will aim for the accelerated uptitration of guideline-directed medical therapy (GDMT) based on haemodynamic tolerance. Haemodynamically guided management will be conducted according to a prespecified protocol (Treatment Protocol) in line with current guidelines for management of chronic heart failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥ 18 years.
- •Able to understand, and willing to provide written informed consent.
- •Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
- •Diagnosis of chronic heart failure in NYHA class II or III
- •Able to stand for 2 minutes
- •Access to necessary resources for participating in a technology-based intervention (smartphone, blood pressure monitor, internet access).
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Use of other services for telemedical monitoring for heart failure.
- •Renal failure with a Glomerular Filtration Rate (GFR) <25 ml/min or requiring renal replacement therapy.
- •Pregnancy, female participant lactating or planning pregnancy during the course of the trial.
- •Complex congenital heart disease
- •Subjects with known pulmonary hypertension (WHO category 1 or 3/4/5)
- •Inability to perform regular measurements alone or with help of a caregiver.
- •Other possible unforeseen medical conditions that the investigator deems unsafe for study participation.
结局指标
主要结局
Heart failure hospitalization and mortality
时间窗: in 6 months
Composite incidence of heart-failure hospitalization or all-cause mortality during an average follow-up of 6 months, assessed against a prespecified performance goal (PG) of 9.0 %
次要结局
- Number of hospitalizations for HF(in 6 months)
- Cardiology visits(in 6 months)
- Patient compliance(in 6 month)
- Medication changes(in 6 months)
- Telephone contacts(in 6 months)