Evidence map›Paper›PMID 29954340›Full record

Trial reportBMC cardiovascular disorders2018

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact).

Claudius Hansen, Christian Loges, Karlheinz Seidl, Frank Eberhardt, Herbert Tröster, Krum Petrov, Gerian Grönefeld, Peter Bramlage, Frank Birkenhauer, Christian Weiss

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cardiovascular disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01200381 (INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems), which is not on this map. Cited by 11 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT01200381 nacompletednot on this map

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems

TypeinterventionalSponsorAbbott Medical DevicesRan2010 to 2014Enrolled210ConditionsHeart FailureArmsQuarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring, Quarterly in clinic follow ups and remote monitoring
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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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

10 authors.

Claudius HansenHerz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem, Humboldtallee 6, 37073, Göttingen, Germany. hansen@hgz-goettingen.de.
Christian LogesSLK-Kliniken Heilbronn Klinikum am Plattenwald, Bad Friedrichshall, Germany.
Karlheinz SeidlKlinikum Ingolstadt, Ingolstadt, Germany.
Frank EberhardtEvangelisches Krankenhaus Kalk, Köln, Germany.
Herbert TrösterMarienhospital Stuttgart, Stuttgart, Germany.
Krum PetrovKreiskliniken Böblingen Standort Sindelfingen, Sindelfingen, Germany.
Gerian GrönefeldAsklepios Klinik Barmbek, Hamburg, Germany.
Peter BramlageInstitut für Pharmakologie und Präventive Medizin, Cloppenburg, Germany.ORCID 0000-0002-4121-6866
Frank BirkenhauerAbbott - St. Jude Medical GmbH, Eschborn, Germany.
Christian WeissStädtisches Klinikum Lüneburg gGmbH, Lüneburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes.

methodsInContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only.

resultsTwo hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients.

conclusionIn HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage.

trial registrationclinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

Indexed as

Defibrillators, ImplantableAgedElectric CountershockGermanyHeart FailureHumansMiddle AgedOffice VisitsPredictive Value of TestsProspective StudiesRemote Sensing TechnologyTelemetryTelephoneTime FactorsTreatment OutcomeCardiac resynchronisation therapy defibrillatorHeart failureImplantable cardioverter defibrillatorPacker heart failure clinical composite responseRemote monitoring

Identifiers

PMID29954340
PMCPMC6025705

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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.