TY  - JOUR
A1  - Störk, Stefan
A1  - Bernhardt, Alexandra
A1  - Böhm, Michael
A1  - Brachmann, Johannes
A1  - Dagres, Nikolaos
A1  - Frantz, Stefan
A1  - Hindricks, Gerd
A1  - Köhler, Friedrich
A1  - Zeymer, Uwe
A1  - Rosenkranz, Stephan
A1  - Angermann, Christiane
A1  - Aßmus, Birgit
T1  - Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial
JF  - Clinical Research in Cardiology
N2  - 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.
KW  - heart failure
KW  - pulmonary artery pressure
KW  - remote monitoring
KW  - CardioMEMS™ HF-System
KW  - randomized controlled trial
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-324026
VL  - 111
IS  - 11
ER  -