The PASSPORT-HF trial is an ongoing study designed to evaluate whether pulmonary artery pressure-guided remote monitoring using the CardioMEMS HF-System reduces unplanned heart failure hospitalizations or all-cause death compared to basic care over 12 months.
RCT (n=554)
Open-label
1:1
Yes
Does pulmonary artery pressure-guided remote monitoring using the CardioMEMS HF-System reduce unplanned HF-related rehospitalizations or all-cause death in adult patients with NYHA class III heart failure?
The PASSPORT-HF trial will determine whether pulmonary artery pressure-guided remote monitoring reduces heart failure hospitalizations and mortality in a German healthcare setting.
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.
Störk et al. (2022) conducted an RCT in Heart failure (NYHA class III) (n=554). CardioMEMS HF-System (PA pressure-guided remote care) vs. Basic HF care alone was evaluated on Composite of the number of unplanned HF-related rehospitalizations or all-cause death. The PASSPORT-HF trial is an ongoing study designed to evaluate whether pulmonary artery pressure-guided remote monitoring using the CardioMEMS HF-System reduces unplanned heart failure hospitalizations or all-cause death compared to basic care over 12 months.