Recent Updates
Recently added Catalysts

Remote Patient Management, Usual Care

Phase 3

Chronic Heart Failure | Unknown | Cardiovascular |Pulmonx Corporation|Last Updated: Aug 3, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,571

FDA Designations

No designations recorded

Clinical trial landscape

Remote Patient Management, Usual Care · 1 trial · 1 indication

Phase 3 1
NCT01878630Telemedical Interventional Management in Heart Failure IIChronic Heart Failure
COMPLETED1,571 Analytics
PHASE3COMPLETED
Telemedical Interventional Management in Heart Failure II
Chronic Heart Failure
NCT018786301,571
Unlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
12 months/ individual-patient follow-up time.

The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.

Secondary Endpoints

All-cause mortality during the individual patient follow-up time.
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
12 months/ individual follow-up time
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
12 months/ individual follow-up time
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Remote Patient ManagementEXPERIMENTALintervention group
Usual CareACTIVE_COMPARATORcontrol group

Interventions

NameTypeDescription
Remote Patient ManagementDEVICEGuideline-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 CareOTHERGuideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites109

Inclusion Criteria: * chronic heart failure New York Heart Association (NYHA) class II or III * echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or \>45% + minimum 1 diuretic in permanent medicinal therapy * hospitalization due to decompensated HF within the last 12mo...

Countries:Germany
Unlock Eligibility Criteria