Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design
Friedrich Koehler, Sebastian Winkler, Michael Schieber, Udo Sechtem, Karl Stangl, Michael Böhm, Herbert Boll, Simone S Kim, Kerstin Koehler, Stephanie Lücke, Marcus Honold, Peter Heinze, Thomas Schweizer, Martin Braecklein, Bridget-Anne Kirwan, Goetz Gelbrich, Stefan D Anker, TIM-HF Investigators, Peter Abele, Erwin Aigeldinger, Carola Anders, Thomas André, Ute Arend, Tayfun Asci, Dorothea Assenov-Lammert, Alexandra Bassen-auf dem Brinke, Gerhard Bauer, Hans-Joachim Becker, Abdullah Behroz, Mark Beling, Hans-Ullrich Biewener, Ulrich Boden, Martin Boitz, Christina Bondke, Janusz Boron, Ulrich Borst, Ralph Brendel, Katharina Brunk, Otto Bubeck, Marianne Buhr, Martin Byrtus, Christophe Dempe, Lutz Dieckmann, Gerhard Doster, Matthias Drescher, Annette Ehlert, Kurt Elser, Meike Engelsing, Erika Etzold, Manuel Fassbender, Frank Finsterbusch, Thomas Frank, Hans-Helmut Friedmann, Angelika Frille, Matthias Gabelmann, Heinruch Gegler, Helmut Gekeler, Kerstin Giese, Gunstram Gola, Marc Oliver Grad, Herwig Greifeneder, Stefan Grün, Ellen Gruner, Heinz Gut, Matthias Gutting, Winfried Haerer, Andreas Hagenow, Rüdiger Hahn, Susanne Hartmann, Corina Haufe, Stefan Haufe, Rüdiger Hechler, Barbara Heda, Konrad Hein, Ingo Herbst, Frank Herpolsheimer, Karl-Michael Hess, Wolfgang Hillinger, René Hintze, Holger Holtz, Azra Hudelmaier, Christian Hueck, Thomas Jaehn, Cornelia Jonuleit, Jörg Kannenberg, Peter Kempf, Alexander Kendzia, Erhard Kiesel, Klaus Kleinbach, Markus Knapp, Rudolf Knorpp, Michael Kobel, Agathe Konietzko, Martin Kraiss, Helmut Krause-Allmendinger, Volker Kühlkamp, Ursula Kühne, Carsten Kurth, Klaus Laskos, Lutz Lenz, Richard Löffler, Jan Lokies, Bruno Löprich, Lucian Lorenz, Manuela Lötsch, Hans Mahler, Tilman Markert, Hellmut Martens, Frank Mayer, Sony Mayerheim, Marion Mende, Gerhard Merz, Werner Metz, Jörg Metzler, Peter Mies, Christine Möller, Swetlana Möller, Paul Morgan, Bernd Moser, Johanna Mulzer, Mohammed Natour, Bernd Neeb, Kristina Niedrig, Djafar Nowzohour, Robert Oeder, George Petcu, Wilhelm Pfeiffer, Lutz-Ulrich Pinkwart, Bernhard Plappert, Christian Pomiersky, Thomas Pötsch, Sabine Pricelius, Frank Pulvermüller, Kersten Putze, Rudolf Raible, Bernhard Rathert, Christiane Reich, Birgit Rek, Berthold Ritter, Frank Röder, Theophil Rommel, Dieter Rösch, Bernward Saurbier, Oliver Scheuermann, Christina Schiefer, Matthias Schlick, Frank Schmitt, Harald Scholz, Thomas Scholz, Dietrich Schultze, Wolfram Schumm, Udo Schwehr, Anke Schwerecke, Christoph Seifart, Thomas Seyfferth, Ludwig Sieroslawski, Josef Simon, Lutz Sinn, Antje Sommerfeldt, Birgit Spangenberg, Cornelius Steffens, Wolfgang Stiller, Erwin Strähle, Ulrike Szerdahelyi, Angelika Tamm, Johannes Tardel, Alexander Theiss, Martin Thriemer, Nikolaus Tiede, Gisela Toncar-Pflumm, Nicole Toursarkissian, Dietmar Treiber, Günther Ulfert, Christian Vogel-Sührig, Dierk-Christian Vogt, Stefan Waldenmaier, Bernhard Weber, Gabriele Wehr, Gerhard Weiss, Bernhard Wickenhäuser, Beate Wild, Heinz-Andreas Willberg, Heike Zeddies, Marianne Zeisler, Stefan Zieger, Hertraud Zietz, Judith Blunert, Oliver Deckwart, Hans-Peter Dübel, René Dziurla, Gunnar Fiss, Christine Gläss, Marrett Heinold, Simone Kim, Friedrich Köhler, Kerstin Köhler, Annett Laurisch, Stephanie Lücke, Sandra Prescher, Brunhilde Schannor, Sibylle Sellmer, Daniel van der Spek, Sebastian Winkler, Daniel Basrai, Gregor Braun, Tüley Derin, Joachim Eckert, Christian Heinrich, Marcus Honold, Reiner Kiebler, Alexandra Lang, Alexandra Looser, Cosima Maier, Esther Müller-Dittner, Ilona Rüssner, Michael Schieber, Sonja Sieprath, Achim Victor, Friedrich Koehler, Sebastian Winkler, Michael Schieber, Udo Sechtem, Karl Stangl, Michael Böhm, Herbert Boll, Simone S Kim, Kerstin Koehler, Stephanie Lücke, Marcus Honold, Peter Heinze, Thomas Schweizer, Martin Braecklein, Bridget-Anne Kirwan, Goetz Gelbrich, Stefan D Anker, TIM-HF Investigators, Peter Abele, Erwin Aigeldinger, Carola Anders, Thomas André, Ute Arend, Tayfun Asci, Dorothea Assenov-Lammert, Alexandra Bassen-auf dem Brinke, Gerhard Bauer, Hans-Joachim Becker, Abdullah Behroz, Mark Beling, Hans-Ullrich Biewener, Ulrich Boden, Martin Boitz, Christina Bondke, Janusz Boron, Ulrich Borst, Ralph Brendel, Katharina Brunk, Otto Bubeck, Marianne Buhr, Martin Byrtus, Christophe Dempe, Lutz Dieckmann, Gerhard Doster, Matthias Drescher, Annette Ehlert, Kurt Elser, Meike Engelsing, Erika Etzold, Manuel Fassbender, Frank Finsterbusch, Thomas Frank, Hans-Helmut Friedmann, Angelika Frille, Matthias Gabelmann, Heinruch Gegler, Helmut Gekeler, Kerstin Giese, Gunstram Gola, Marc Oliver Grad, Herwig Greifeneder, Stefan Grün, Ellen Gruner, Heinz Gut, Matthias Gutting, Winfried Haerer, Andreas Hagenow, Rüdiger Hahn, Susanne Hartmann, Corina Haufe, Stefan Haufe, Rüdiger Hechler, Barbara Heda, Konrad Hein, Ingo Herbst, Frank Herpolsheimer, Karl-Michael Hess, Wolfgang Hillinger, René Hintze, Holger Holtz, Azra Hudelmaier, Christian Hueck, Thomas Jaehn, Cornelia Jonuleit, Jörg Kannenberg, Peter Kempf, Alexander Kendzia, Erhard Kiesel, Klaus Kleinbach, Markus Knapp, Rudolf Knorpp, Michael Kobel, Agathe Konietzko, Martin Kraiss, Helmut Krause-Allmendinger, Volker Kühlkamp, Ursula Kühne, Carsten Kurth, Klaus Laskos, Lutz Lenz, Richard Löffler, Jan Lokies, Bruno Löprich, Lucian Lorenz, Manuela Lötsch, Hans Mahler, Tilman Markert, Hellmut Martens, Frank Mayer, Sony Mayerheim, Marion Mende, Gerhard Merz, Werner Metz, Jörg Metzler, Peter Mies, Christine Möller, Swetlana Möller, Paul Morgan, Bernd Moser, Johanna Mulzer, Mohammed Natour, Bernd Neeb, Kristina Niedrig, Djafar Nowzohour, Robert Oeder, George Petcu, Wilhelm Pfeiffer, Lutz-Ulrich Pinkwart, Bernhard Plappert, Christian Pomiersky, Thomas Pötsch, Sabine Pricelius, Frank Pulvermüller, Kersten Putze, Rudolf Raible, Bernhard Rathert, Christiane Reich, Birgit Rek, Berthold Ritter, Frank Röder, Theophil Rommel, Dieter Rösch, Bernward Saurbier, Oliver Scheuermann, Christina Schiefer, Matthias Schlick, Frank Schmitt, Harald Scholz, Thomas Scholz, Dietrich Schultze, Wolfram Schumm, Udo Schwehr, Anke Schwerecke, Christoph Seifart, Thomas Seyfferth, Ludwig Sieroslawski, Josef Simon, Lutz Sinn, Antje Sommerfeldt, Birgit Spangenberg, Cornelius Steffens, Wolfgang Stiller, Erwin Strähle, Ulrike Szerdahelyi, Angelika Tamm, Johannes Tardel, Alexander Theiss, Martin Thriemer, Nikolaus Tiede, Gisela Toncar-Pflumm, Nicole Toursarkissian, Dietmar Treiber, Günther Ulfert, Christian Vogel-Sührig, Dierk-Christian Vogt, Stefan Waldenmaier, Bernhard Weber, Gabriele Wehr, Gerhard Weiss, Bernhard Wickenhäuser, Beate Wild, Heinz-Andreas Willberg, Heike Zeddies, Marianne Zeisler, Stefan Zieger, Hertraud Zietz, Judith Blunert, Oliver Deckwart, Hans-Peter Dübel, René Dziurla, Gunnar Fiss, Christine Gläss, Marrett Heinold, Simone Kim, Friedrich Köhler, Kerstin Köhler, Annett Laurisch, Stephanie Lücke, Sandra Prescher, Brunhilde Schannor, Sibylle Sellmer, Daniel van der Spek, Sebastian Winkler, Daniel Basrai, Gregor Braun, Tüley Derin, Joachim Eckert, Christian Heinrich, Marcus Honold, Reiner Kiebler, Alexandra Lang, Alexandra Looser, Cosima Maier, Esther Müller-Dittner, Ilona Rüssner, Michael Schieber, Sonja Sieprath, Achim Victor
Abstract
Remote patient management (telemonitoring) may help to detect early signs of cardiac decompensation, allowing optimization of and adherence to treatments in chronic heart failure (CHF). Two meta-analyses have suggested that telemedicine in CHF can reduce mortality by 30-35%. The aim of the TIM-HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients. Methods CHF patients [New York Heart Association (NYHA) II/III, left ventricular ejection fraction (LVEF)≤35%] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months (no decompensation required if LVEF≤25%) were randomized 1:1 to an intervention group of daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support or to usual care led by the patients' local physician. In the intervention group, 24/7 physician-led medical support was provided by two central telemedical centres. A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization. The primary endpoint was total mortality. The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure. Other secondary endpoints included cardiovascular mortality, all-cause and cause-specific hospitalizations (all time to first event) as well as days lost due to heart failure hospitalization or cardiovascular death (in % of follow-up time), and changes in quality of life and NYHA class. Overall, 710 CHF patients were recruited. The mean follow-up was 21.5±7.2 months, with a minimum of 12 months. Perspective The study will provide important prospective outcome data on the impact of telemedical management in patients with CHF.
Source: PubMed