Seated Pulmonary Artery Pressure Management in Patients With Heart Failure: 12-Month Outcomes of the PROACTIVE-HF Trial (JACC Heart Failure June 2026)-Article: Seated Pulmonary Artery Pressure Management in Patients With Heart Failure: 12-Month Outcomes of the PROACTIVE-HF Trial

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The PROACTIVE-HF trial evaluated whether remote heart failure management using the Cordella pulmonary artery sensor system, which measures seated mean pulmonary artery pressure (mPAP) plus vital signs, could improve outcomes over 12 months in NYHA class III heart failure patients across the ejection fraction spectrum.<br /><br />This was an open-label, single-arm study across 75 centers in Europe and the U.S. A total of 456 implanted patients formed the modified intent-to-treat cohort; 44.1% had HFpEF, 45.6% had HFrEF, and 9.9% had HFmrEF. Clinicians used daily pressure and vital sign data to adjust guideline-directed medical therapy, vasodilators, and diuretics toward a seated mPAP target of 5–20 mm Hg.<br /><br />The main 12-month effectiveness endpoint, HF hospitalization or all-cause mortality, was 0.36 events per patient, significantly below the prespecified performance goal of 0.70 (P < 0.0001). Event rates were similar between the newly enrolled single-arm patients and the former treatment arm, while the former control arm had higher rates. Safety remained favorable, with no new device/system-related complications or pressure sensor failures after 6 months.<br /><br />Patients also showed meaningful clinical improvement: Kansas City Cardiomyopathy Questionnaire scores, 6-minute walk distance, NYHA class, and NT-proBNP all improved significantly. Hemodynamics responded as intended: patients with elevated baseline mPAP had reductions, while those below target tended to rise modestly but generally stayed within range. Medication titration was frequent, especially diuretics, and doses of several HF therapies increased over time.<br /><br />Overall, the study supports seated mPAP-guided remote management as a safe strategy associated with fewer HF hospitalizations and deaths, better quality of life, and improved functional status through 12 months.

Meta Tag

Concept PROACTIVE-HF Trial

Concept Seated Mean Pulmonary Artery Pressure

Concept Heart Failure

Concept Implantable Pulmonary Artery Pressure Remote Hemodynamic Monitoring

Concept Cordella Pulmonary Artery Sensor System

Keywords

PROACTIVE-HF trial

heart failure remote management

Cordella pulmonary artery sensor

mean pulmonary artery pressure

NYHA class III

HF hospitalization

all-cause mortality

HFpEF HFrEF HFmrEF

guideline-directed medical therapy

Kansas City Cardiomyopathy Questionnaire

PROACTIVE-HF Trial

Seated Mean Pulmonary Artery Pressure

Heart Failure

Implantable Pulmonary Artery Pressure Remote Hemodynamic Monitoring

Cordella Pulmonary Artery Sensor System