- Titel
- Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT‑HF)
- Untertitel
- rationale and design of the PASSPORT‑HF multicenter randomized clinical trial
- Zitierfähige Url:
- https://nbn-resolving.org/urn:nbn:de:bsz:15-qucosa2-1038932
- Quellenangabe
- Clinical Research in Cardiology
Erscheinungsjahr: 2022
Jahrgang: 111
Heft: 11
Seiten: 1245-1255
ISSN: 1861-0684
E-ISSN: 1861-0692 - Erstveröffentlichung
- 2022
- Abstract (EN)
- 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.
- Andere Ausgabe
- Erstveröffentlichung
DOI: 10.1007/s00392-022-01987-3 - Freie Schlagwörter (EN)
- Heart failure, Pulmonary artery pressure, Remote monitoring, CardioMEMS™ HF-System, Randomized controlled trial
- Klassifikation (DDC)
- 610
- Verlag
- Springer, Berlin, Heidelberg
- Version / Begutachtungsstatus
- publizierte Version / Verlagsversion
- URN Qucosa
- urn:nbn:de:bsz:15-qucosa2-1038932
- Veröffentlichungsdatum Qucosa
- 17.04.2026
- Dokumenttyp
- Artikel
- Sprache des Dokumentes
- Englisch
- Lizenz / Rechtehinweis
CC BY 4.0