RATIONALE AND DESIGN OF THE PROACTIVE-HF TRIAL FOR MANAGING NYHA CLASS III HEART FAILURE PATIENTS WITH THE COMBINED CORDELLA(TM) PULMONARY ARTERY SENSOR AND THE CORDELLA(TM) HEART FAILURE SYSTEM
Guichard JL, Cowger JA, Chaparro SV, Kiernan MS, Mullens W, Mahr C, Mullin C, Forouzan O, Hiivala NJ, Sauerland A, Leadley K, and Klein L. RATIONALE AND DESIGN OF THE PROACTIVE-HF TRIAL FOR MANAGING NYHA CLASS III HEART FAILURE PATIENTS WITH THE COMBINED CORDELLA(TM) PULMONARY ARTERY SENSOR AND THE CORDELLA(TM) HEART FAILURE SYSTEM. J Card Fail 2022.
Journal of cardiac failure
BACKGROUND: Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in heart failure (HF) patients are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, 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, randomized, controlled, single-blind, multi-center trial to evaluate the safety and effectiveness of the Cordella(TM) PAP Sensor in HF patients with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management 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 pre-specified safety and effectiveness endpoints to provide evidence for a similar risk-benefit profile as the CardioMEMS(TM) HF System.
CONCLUSION: The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management in NYHA class III patients. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.
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