Evidence map›Paper›PMID 35246723›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2022

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

Stefan Störk, Alexandra Bernhardt, Michael Böhm, Johannes Brachmann, Nikolaos Dagres, Stefan Frantz, Gerd Hindricks, Friedrich Köhler, Uwe Zeymer, Stephan Rosenkranz and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04398654 (Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04398654 naactive not recruitingnot on this map

Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes

TypeinterventionalSponsorIHF GmbH - Institut für HerzinfarktforschungRan2020 to 2026Enrolled554ConditionsHeart FailureArmsCardioMEMSTM HF sensor - pulmonary artery pressure measurement
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 28 citations in OpenAlex.

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  8. Challenging the status quo: a scoping review of value-based care models in cardiology and electrophysiology.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
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  10. [Legal aspects of telemedicine in cardiology in Germany].Herzschrittmachertherapie & Elektrophysiologie · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 1 country.

Stefan StörkComprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany. Stoerk_S@ukw.de.ORCID http://orcid.org/0000-0002-1771-7249
Alexandra BernhardtInstitut für Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.
Michael BöhmDepartment of Internal Medicine III, University Hospital, Saarland University, Homburg/Saar, Germany.
Johannes BrachmannDepartment of Internal Medicine II, Klinikum Coburg GmbH, Coburg, Germany.
Nikolaos DagresLeipzig Heart Institute, Leipzig, Germany.
Stefan FrantzComprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.
Gerd HindricksLeipzig Heart Institute, Leipzig, Germany.
Friedrich KöhlerCenter for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.
Uwe ZeymerInstitut für Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.
Stephan Rosenkranz *Ludwigshafen Hospital, Ludwigshafen, Germany.
Christiane Angermann *Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.
Birgit Aßmus *Department of Internal Medicine I, University Hospital Gießen and Marburg, Gießen, Germany.
Leipzig Heart Institute · DEUniversitätsklinikum Würzburg · DECharité - Universitätsmedizin Berlin · DEKlinikum Coburg · DEKlinikum Ludwigshafen · DELudwigshafen University of Business and Society · DESaarland University · DEStiftung Institut für Herzinfarktforschung · DEUniversitäts-Kinderklinik Würzburg · DEUniversitätsklinikum Gießen und Marburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRemote 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.

objectivesPASSPORT-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

resultsThe 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.

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

trial registrationClinicalTrials.gov; NCT04398654, 13-MAY-2020.

Indexed as

Heart FailureHemodynamic MonitoringAdultAftercareBlood Pressure Monitoring, AmbulatoryHumansMulticenter Studies as TopicPatient DischargeProspective StudiesPulmonary ArteryQuality of LifeRandomized Controlled Trials as TopicCardioMEMS™ HF-SystemHeart failurePulmonary artery pressureRandomized controlled trialRemote monitoring

Identifiers

PMID35246723
PMCPMC8896072
OpenAlexW4214900076

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.