Telemedical Interventional Management in Heart Failure II

Study Overview
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Brief Summary
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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

Detailed Description
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The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Official Title
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Telemedical Interventional Management in Heart Failure II

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Remote Patient Management
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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 12months before randomization informed consent Depression score PHQ-9: <10 Exclusion Criteria: hospitalization within the last 7 days before randomization implanted cardiac assist system acute coronary syndrome within the last 7 days before randomization high urgent listed for heart transplantation (HTx) planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization revascularization and/or CRT-implantation within 28 days before randomization known alcohol or drug abuse terminal renal insufficiency with hemodialysis impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate) existence of any disease reducing life expectancy to less than 1 year age <18 years pregnancy participation in other treatment studies or remote patient management programmes (register studies possible)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Patient Management<br>intervention group | Device: Remote Patient Management<br>* 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)<br>* Other names: R&D project Fontane;|
| Active Comparator: Usual Care<br>control group | Other: Usual Care<br>* Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality during the individual patient follow-up time. | All-cause and cardiovascular mortality will be calculated as: The individual follow-up time as calculated for the primary outcome + 28 days for all patients to a maximum of 393 days. | 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 | 
| Change in MLHFQ-questionnaire overall score between baseline and 365 days | The change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) scores will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided. | 12 months/ individual follow-up time | 
| Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days. | The change in NT-proBNP and of MR-proADM levels will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided | 12 months/ individual follow-up time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Heart Failure, CHF