CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,571 enrolled
Drug / intervention
Remote Patient Management +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01878630
NCT01878630Phase 3Completed
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Telemedical Interventional Management in Heart Failure II

Charite University, Berlin, Germany·interventional·Posted Jun 17, 2013·Updated Aug 3, 2018

In Brief

A Phase 3 clinical trial evaluating Remote Patient Management and Usual Care for Chronic Heart Failure. Completed, enrolled 1,571 participants across 109 sites.

Detailed Summary

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.: * days lost due to unplanned cardiovascular hospitalization or death * all-cause mortality * cardiovascular mortality * quality of life

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesGermany
CollaboratorsGerman Federal Ministry of Education and Research, University of Leipzig

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 17, 2013
Enrollment StartAug 8, 2013
Primary CompletionMay 12, 2017
Study CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.0 years ago

Interventions

Remote Patient Managementdevice

Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status: * weighing scale (Seca 861 with bluetooth, seca gmbh \& co. kg.) * blood pressure device (UA767PBT with bluetooth, A\&D Ltd.) * ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG) * patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG) * help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB) at center site: \- electronic patient record (eHealth connect 2.0, T-Systems International)

Usual Careother

Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)