Clinical trial NCT04613401: Influence of Telemonitoring on the Management of LVAD-patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ventricular Assist Device
Telemedicine
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with terminal heart failure and LVAD-therapy who are monitored by telemedicine.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of days spent in the hospital due to VAD-associated complications
timeFrame: 6 months
Secondary outcomes:
measure: Change in quality of life from baseline
timeFrame: 6 months
measure: Change in depression from baseline
timeFrame: 6 months
measure: Number of VAD-associated complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen
state: NRW
Study officials:
References:
citation: Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz - Langfassung, 2. Auflage. Version 3. 2017.
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citation: 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.
citation: 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.
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citation: 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.
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