PMID- 35246723
OWN - NLM
STAT- MEDLINE
DCOM- 20221102
LR  - 20221102
IS  - 1861-0692 (Electronic)
IS  - 1861-0684 (Print)
IS  - 1861-0684 (Linking)
VI  - 111
IP  - 11
DP  - 2022 Nov
TI  - Pulmonary artery sensor system pressure monitoring to improve heart failure 
      outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter 
      randomized clinical trial.
PG  - 1245-1255
LID - 10.1007/s00392-022-01987-3 [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Stork, Stefan
AU  - Stork S
AUID- ORCID: 0000-0002-1771-7249
AD  - Comprehensive Heart Failure Center, University and University Hospital Wurzburg, 
      Am Schwarzenberg 15, 97078, Wurzburg, Germany. Stoerk_S@ukw.de.
AD  - Department of Internal Medicine I, University Hospital Wurzburg, Wurzburg, 
      Germany. Stoerk_S@ukw.de.
FAU - Bernhardt, Alexandra
AU  - Bernhardt A
AD  - Institut fur Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.
FAU - Bohm, Michael
AU  - Bohm M
AD  - Department of Internal Medicine III, University Hospital, Saarland University, 
      Homburg/Saar, Germany.
FAU - Brachmann, Johannes
AU  - Brachmann J
AD  - Department of Internal Medicine II, Klinikum Coburg GmbH, Coburg, Germany.
FAU - Dagres, Nikolaos
AU  - Dagres N
AD  - Leipzig Heart Institute, Leipzig, Germany.
AD  - Department of Electrophysiology, Heart Center Leipzig at the University of 
      Leipzig, Leipzig, Germany.
FAU - Frantz, Stefan
AU  - Frantz S
AD  - Comprehensive Heart Failure Center, University and University Hospital Wurzburg, 
      Am Schwarzenberg 15, 97078, Wurzburg, Germany.
AD  - Department of Internal Medicine I, University Hospital Wurzburg, Wurzburg, 
      Germany.
FAU - Hindricks, Gerd
AU  - Hindricks G
AD  - Leipzig Heart Institute, Leipzig, Germany.
AD  - Department of Electrophysiology, Heart Center Leipzig at the University of 
      Leipzig, Leipzig, Germany.
FAU - Kohler, Friedrich
AU  - Kohler F
AD  - Center for Cardiovascular Telemedicine, Charite Universitatsmedizin Berlin, 
      Campus Mitte, Berlin, Germany.
FAU - Zeymer, Uwe
AU  - Zeymer U
AD  - Institut fur Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.
AD  - Department of Cardiology, Heart Centre Ludwigshafen, Ludwigshafen, Germany.
FAU - Rosenkranz, Stephan
AU  - Rosenkranz S
AD  - Ludwigshafen Hospital, Ludwigshafen, Germany.
FAU - Angermann, Christiane
AU  - Angermann C
AD  - Comprehensive Heart Failure Center, University and University Hospital Wurzburg, 
      Am Schwarzenberg 15, 97078, Wurzburg, Germany.
FAU - Assmus, Birgit
AU  - Assmus B
AD  - Department of Internal Medicine I, University Hospital Giessen and Marburg, 
      Giessen, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT04398654
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220304
PL  - Germany
TA  - Clin Res Cardiol
JT  - Clinical research in cardiology : official journal of the German Cardiac Society
JID - 101264123
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Hemodynamic Monitoring
MH  - Pulmonary Artery
MH  - Blood Pressure Monitoring, Ambulatory
MH  - Quality of Life
MH  - Prospective Studies
MH  - Aftercare
MH  - Patient Discharge
MH  - *Heart Failure/therapy/drug therapy
PMC - PMC8896072
OTO - NOTNLM
OT  - CardioMEMS HF-System
OT  - Heart failure
OT  - Pulmonary artery pressure
OT  - Randomized controlled trial
OT  - Remote monitoring
EDAT- 2022/03/06 06:00
MHDA- 2022/11/03 06:00
PMCR- 2022/03/04
CRDT- 2022/03/05 05:30
PHST- 2021/10/11 00:00 [received]
PHST- 2022/01/18 00:00 [accepted]
PHST- 2022/03/06 06:00 [pubmed]
PHST- 2022/11/03 06:00 [medline]
PHST- 2022/03/05 05:30 [entrez]
PHST- 2022/03/04 00:00 [pmc-release]
AID - 10.1007/s00392-022-01987-3 [pii]
AID - 1987 [pii]
AID - 10.1007/s00392-022-01987-3 [doi]
PST - ppublish
SO  - Clin Res Cardiol. 2022 Nov;111(11):1245-1255. doi: 10.1007/s00392-022-01987-3. 
      Epub 2022 Mar 4.