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

Background: Optimizing guideline-directed medical therapy (GDMT) and monitoring conges-tion in patients with heart failure (HF) are key to disease management and preventing hospi-talizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symp-toms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management. Methods: The PROACTIVE-HF study was originally approved in 2018 as a prospective, random-ized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) func-tional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF man-agement has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System. Conclusion: The single-arm PROACTIVE-HF trial is expected to further demonstrate the bene-fits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management. (J Cardiac Fail 2023;29:171-180)