Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial

Abstract

Background: Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients.

Objectives: PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points.

Methods and results: The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression.

Conclusions: PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.

Trial registration: ClinicalTrials.gov; NCT04398654, 13-MAY-2020.

Keywords: CardioMEMS™ HF-System; Heart failure; Pulmonary artery pressure; Randomized controlled trial; Remote monitoring.

© 2022. The Author(s).

Figures

Fig. 1

Participating centers in Germany

Fig. 2

The CardioMEMS™ HF-System. The CardioMEMS pulmonary artery (PA) pressure sensor is shown (top, left), with its placement in the left PA. The sensor has a vertical orientation if the patient sits upright. After implantation, while still in hospital, the patient is instructed by trained staff how to position him/herself on the pillow that contains the measurement unit and measure and transmit the PA pressures once daily. The transmitted values can be accessed via a safe website by the heart failure nurse. Individual PA measurements (with tracings, see bottom right) and PA trends over time are visualized on the dashboard, allowing to interpret values in the context of supplementary information

Fig. 3

PASSPORT-HF trial follow-up scheme. R: central randomization 1:1, stratified by study site. NYHA, New York Heart Association; PA, pulmonary artery