Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor and the Cordella Heart Failure System

Journal of Cardiac Failure(2023)

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摘要
•The PROACTIVE-HF trial is designed to assess the benefit of personalized and proactive management of patients with class III heart failure (HF) guided by daily measurements of pulmonary artery pressure (PAP) pressures in combination with weight, blood pressure, heart rate, blood oxygen saturation, and symptoms.•The investigational Cordella Sensor System is designed to achieve high levels of patient engagement and compliance by the use of a small hand-held reader placed over an anteriorly implanted sensor, facilitating patient-friendly seated PAP measurements and a modern digital health app providing patients with timely education, real-time feedback and tools for easy 2-way communication with the care providers.•Key trial hypotheses are that HF management using PAP in combination with additional vital-sign parameters will provide the dual benefits of congestion management and GDMT optimization and that patient engagement and compliance will positively impact remote medical management decisions and patient outcomes.
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关键词
Remote patient monitoring,heart failure,GDMT,clinical trial,6-minute walk test
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