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Heart FailureNCT04613401

Influence of Telemonitoring on the Management of LVAD-patients

An observational study of Heart Failure and Ventricular Assist Device, run by University Hospital, Essen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
questionnaire (observational study)
How many people
50 participants
Where
1 siteGermany
Study dates
1 Jul 2020to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with terminal heart failure and LVAD-therapy who are monitored by telemedicine.

Who may be able to join

  • Age> 18 years
  • Indication for telemedicine
  • Permanently implanted left ventricular assist device (VAD)

Who cannot join

  • no possibility of telephone contact
  • patient does not speak german
  • incompliance
  • rejection or inability to give consent

Trial locations and contacts

1 site in 1 country.

Julia Hoffmann contact

+49 201 723 85587

julia.hoffmann@uk-essen.de

Germany1 site, 1 recruiting

  • Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen

    Essen, North Rhine-Westphalia, 45147

    Julia Hoffmann, +49 201 723 85587, julia.hoffmann@uk-essen.de

    Recruiting

Other trials in Germany

About this study

Official title: Association of Telemonitoring With Hospitalization Rates and Quality of Life in Patients With End-stage Heart Failure and Implanted Left Ventricular Cardiac Assist Devices

The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.

Being tested
questionnaire (observational study)
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire (observational study)Other

    questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)

Study groups in NCT04613401
Study groupRoleWhat they receive
VAD-patients with TelemonitoringNot described
Receives: Other: questionnaire (observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days spent in the hospital due to VAD-associated complications

    VAD-associated complications are defined as

    • bleeding with the need for a transfusion
    • infection with the need for an antibiotic therapy
    • thrombosis with the need for a lysis therapy

    Measured: 6 months

Secondary outcomes (3)

  1. Change in quality of life from baseline

    Quality of life will be assessed with the "Kansas City Cardiomyopathy Questionnaire (KCCQ) "

    -> The raw values of the domains are transformed to a scale from 0 to 100, where high values indicate good condition.

    Measured: 6 months

  2. Change in depression from baseline

    • Depression will be assessed with the "Patient Health Questionnaire eight-item depression scale" (PHQ-8)

    -> The raw values of the domains are transformed to a scale from 0 to 24, where high values indicate a depression.

    Measured: 6 months

  3. Number of VAD-associated complications

    VAD-associated complications are defined as

    • bleeding with the need for a transfusion
    • infection with the need for an antibiotic therapy
    • thrombosis with the need for a lysis therapy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start1 Jul 2020
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04613401
Sponsor's protocol ID
20-9312-BO
Status last verified
Nov 2020
First submitted
26 Oct 2020
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz - Langfassung, 2. Auflage. Version 3. 2017.

  • Bundesauswertung zum Erfassungsjahr 2018: Herzunterstützungssysteme/Kunstherzen; Qualitätsindikatoren und Kennzahlen. IQTIG - Institut für Qualitätssicherung und Transparenz im Gesundheitswesen; 2019 .

  • Reiss N, Schmidt T, Boeckelmann M, Schulte-Eistrup S, Hoffmann JD, Feldmann C, Schmitto JD. Telemonitoring of left-ventricular assist device patients-current status and future challenges. J Thorac Dis. 2018 Jun;10(Suppl 15):S1794-S1801. doi: 10.21037/jtd.2018.01.158.

    PubMed 30034855

  • Kimura M, Nawata K, Kinoshita O, Yamauchi H, Hoshino Y, Hatano M, Amiya E, Kashiwa K, Endo M, Kagami Y, Nemoto M, Ono M. Readmissions after continuous flow left ventricular assist device implantation. J Artif Organs. 2017 Dec;20(4):311-317. doi: 10.1007/s10047-017-0975-4. Epub 2017 Jul 27.

    PubMed 28752193

  • Smedira NG, Hoercher KJ, Lima B, Mountis MM, Starling RC, Thuita L, Schmuhl DM, Blackstone EH. Unplanned hospital readmissions after HeartMate II implantation: frequency, risk factors, and impact on resource use and survival. JACC Heart Fail. 2013 Feb;1(1):31-9. doi: 10.1016/j.jchf.2012.11.001. Epub 2013 Feb 4.

    PubMed 24621797

  • Reiss N, Wegner KK, Hoffmann JD, Schulte Eistrup S, Boeken U, Morshuis M, Schmidt T. Requirements for a Telemedicine Center to Monitor LVAD Patients. Stud Health Technol Inform. 2019;260:146-153.

    PubMed 31118331

  • Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Kaab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016 Nov 1;37(41):3154-3163. doi: 10.1093/eurheartj/ehw099. Epub 2016 Mar 16.

    PubMed 26984864

  • Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.

    PubMed 25131977

  • Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

    PubMed 30153985

  • Berg T, Tewarie L, Moza A, Zayat R, Autschbach R, Stoppe C, Goetzenich A, Benstoem C. [Requirements for outpatient care after implantation of a ventricular assist device : Views of patients and their relatives]. Herz. 2019 May;44(3):257-264. doi: 10.1007/s00059-017-4636-4. Epub 2017 Oct 27. German.

    PubMed 29079934

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Ventricular Assist Device, run by University Hospital, Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julia Hoffmann (+49 201 723 85587, julia.hoffmann@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days spent in the hospital due to VAD-associated complications (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04613401, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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