Telemedical Interventional Management in Heart Failure II

Phase 3

Completed

• Conditions: Chronic Heart Failure
• Interventions: Device: Remote Patient Management; Other: Usual Care

• Registration Number: NCT01878630
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Study Start: 2013-08-08
• Primary Completion: 2017-05-12
• Study Completion: 2018-05-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1571

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Patient Management	Remote Patient Management	intervention group
Usual Care	Usual Care	control group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time	12 months/ individual follow-up time
Percentage of days lost due to unplanned cardiovascular 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	12 months/ individual follow-up time	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.
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.	12 months/ individual follow-up time	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
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)	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.

Trial Locations

Locations (107)

Klinikum St. Marien Amberg - Medizinische Klinik I; 🇩🇪 Amberg, Germany

Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie; 🇩🇪 Bad Belzig, Germany

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Bundeswehr Krankenhaus; 🇩🇪 Berlin, Germany

Oder-Spree-Krankenhaus Beeskow GmbH; 🇩🇪 Beeskow, Germany

Cardio Centrum Berlin GmbH; 🇩🇪 Berlin, Germany

Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin; 🇩🇪 Berlin, Germany

Gemeinschaftspraxis am Bayerischen Platz; 🇩🇪 Berlin, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Jüdisches Krankenhaus Berlin; 🇩🇪 Berlin, Germany

HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH; 🇩🇪 Berlin, Germany

Herzpraxis Berlin; 🇩🇪 Berlin, Germany

Kardiologische Praxis im Spreebogen; 🇩🇪 Berlin, Germany

Kardiologie Weissensee; 🇩🇪 Berlin, Germany

Kranoldpraxis; 🇩🇪 Berlin, Germany

Krankenhaus Waldfriede e. V.; 🇩🇪 Berlin, Germany

Martin-Luther Krankenhaus; 🇩🇪 Berlin, Germany

MVZ Treffpunkt Geißenweide GmbH; 🇩🇪 Berlin, Germany

Praxis am Dachsbau; 🇩🇪 Berlin, Germany

Polikum Institut GmbH Polikum Friede; 🇩🇪 Berlin, Germany

Praxis Frank; 🇩🇪 Berlin, Germany

Praxis Claus; 🇩🇪 Berlin, Germany

Praxis Dres. Weinrich; 🇩🇪 Berlin, Germany

Praxis Pinkwart; 🇩🇪 Berlin, Germany

Praxis Roeder; 🇩🇪 Berlin, Germany

Vivantes Klinikum Hellersdorf; 🇩🇪 Berlin, Germany

Vivantes MVZ Wedding; 🇩🇪 Berlin, Germany

Ärzte Schönhauser Berlin e.V.; 🇩🇪 Berlin, Germany

Brandenburgklinik Berlin-Brandenburg GmbH; 🇩🇪 Bernau, Germany

Immanuel Klinikum Bernau, Herzzentrum Brandenburg; 🇩🇪 Bernau, Germany

Kardiologische Praxis Gola; 🇩🇪 Bernau, Germany

Gemeinschaftspraxis Hampel/Janoske; 🇩🇪 Bitterfeld-Wolfen, Germany

Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor; 🇩🇪 Bitterfeld-Wolfen, Germany

Städtisches Klinikum Brandenburg/Havel; 🇩🇪 Brandenburg/Havel, Germany

Herz - und Gefäßzentrum am Neumarkt; 🇩🇪 Celle, Germany

Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH; 🇩🇪 Chemnitz, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Carl-Thiem-Klinikum Cottbus; 🇩🇪 Cottbus, Germany

Klinikum Lippe - Kardiologie; 🇩🇪 Detmold, Germany

Städtisches Klinikum Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Cardiologicum Dresden & Pirna; 🇩🇪 Dresden, Germany

Klinikum Barnim GmbH, Werner Forßmann Krankenhaus; 🇩🇪 Eberswalde, Germany

Kreisklinik Ebersberg gGmbH; 🇩🇪 Ebersberg, Germany

Klinikum der Johann-Wolfgang Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Praxis Langel; 🇩🇪 Gera, Germany

Kardiologische Praxis Dr. Wehr; 🇩🇪 Gerlingen, Germany

Cardiocampus - Kardiologische Gemeinschaftspraxis; 🇩🇪 Gifhorn, Germany

Praxis Dr. med. Frank Warzok; 🇩🇪 Gotha, Germany

Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH; 🇩🇪 Hamburg, Germany

Praxis Karsten Müller; 🇩🇪 Gräfenhainichen, Germany

Praxis Dr. med Karsten Müller; 🇩🇪 Gräfenhainichen, Germany

Universitätsklinikum Halle (Saale); 🇩🇪 Halle, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin; 🇩🇪 Hannover, Germany

Asklepios Klinik Langen; 🇩🇪 Langen, Germany

HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin; 🇩🇪 Köthen (Anhalt), Germany

Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie; 🇩🇪 Leipzig, Germany

Cardio Centrum Ludwigsburg Bietigheim; 🇩🇪 Ludwigsburg, Germany

MVZ Lübbenau GmbH; 🇩🇪 Lübbenau, Germany

Praxis Horn; 🇩🇪 Manschnow, Germany

Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4; 🇩🇪 Malchin, Germany

Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf; 🇩🇪 Magdeburg, Germany

Kardiologische Praxis Dr. Rheinert; 🇩🇪 Merzig, Germany

Praxis Dr. med. Dieter Böhm; 🇩🇪 Marbach, Germany

Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg; 🇩🇪 Merseburg, Germany

Praxis Dr. Jens Taggeselle; 🇩🇪 Markkleeberg, Germany

Dietrich Bonhoeffer Klinikum; 🇩🇪 Neubrandenburg, Germany

Kardiologie Mühldorf am Inn; 🇩🇪 Mühldorf Am Inn, Germany

Kardiologische Praxis Nauen; 🇩🇪 Nauen, Germany

Ruppiner Kliniken GmbH; 🇩🇪 Neuruppin, Germany

Kardiologische Praxis Dr. H.P. Mieg; 🇩🇪 Oranienburg, Germany

Praxis Donaubauer; 🇩🇪 Oschatz, Germany

Kreiskrankenhaus Prignitz gGmbH; 🇩🇪 Perleberg, Germany

Internist; Facharzt für Innere Medizin; 🇩🇪 Pasewalk, Germany

St. Josefs-Krankenhaus Potsdam-Sanssouci; 🇩🇪 Potsdam, Germany

Poliklinik Ernst von Bergmann GmbH; 🇩🇪 Potsdam, Germany

Praxis Ehlert; 🇩🇪 Pritzwalk, Germany

Kardiologische Gemeinschaftspraxis am Park Sanssouci; 🇩🇪 Potsdam, Germany

Facharzt-Zentrum Pneumologie und Kardiologie; 🇩🇪 Rüdersdorf, Germany

Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto; 🇩🇪 Riesa, Germany

Kardiologische Praxis Dr. Placke; 🇩🇪 Rostock, Germany

Klinik am See/REHA-Fachklinik für Innere Medizin; 🇩🇪 Rüdersdorf, Germany

Praxis für Kardiologie; 🇩🇪 Seelow, Germany

Thüringen-Kliniken "Georgius Agricola"; 🇩🇪 Saalfeld/Saale, Germany

Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim; 🇩🇪 Schopfheim, Germany

Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie; 🇩🇪 Schneeberg, Germany

Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH; 🇩🇪 Schwedt/Oder, Germany

Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg; 🇩🇪 Senftenberg, Germany

Johanniter-Krankenhaus Genthin-Stendal GmbH; 🇩🇪 Stendal, Germany

Internistische Gemeinschaftspraxis Steiner Thor; 🇩🇪 Straubing, Germany

Klinikum St. Elisabeth Straubing GmbH; 🇩🇪 Straubing, Germany

Kardiologische Facharztpraxis Dr. med. Heike Olthoff; 🇩🇪 Strausberg, Germany

Robert Bosch Krankenhaus Stuttgart; 🇩🇪 Stuttgart, Germany

Internistische Praxis am Landsberger Tor; 🇩🇪 Strausberg, Germany

Kardiologische Gemeinschaftspraxis Wittenberg; 🇩🇪 Wittenberg, Germany

Sana-Kliniken Berlin-Brandenburg GmbH; 🇩🇪 Templin, Germany

Praxis Stiller; 🇩🇪 Wittstock, Germany

Ambulantes Herz-Kreislauf Zentrum Wolfsburg; 🇩🇪 Wolfsburg, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Praxis Lägel; 🇩🇪 Zeuthen, Germany

DRK Kliniken Berlin-Köpenick; 🇩🇪 Berlin, Germany

GLG Fachklinik Wolletzsee GmbH; 🇩🇪 Angermünde, Germany

Praxis Hagenow; 🇩🇪 Elsterwerda, Germany

Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus; 🇩🇪 Königs-Wusterhausen, Germany

Kardiologie im Praxishaus; 🇩🇪 Kleinmachnow, Germany

Cardiologicum; 🇩🇪 Pirna, Germany

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany