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1. Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial

Author

Axel Bauer, ProfMD, Nikolay Sappler, MD, Lukas von Stülpnagel, PhD, Mathias Klemm, MD, Michael Schreinlechner, MD, Felix Wenner, MD, Johannes Schier, MD, Amani Al Tawil, MSc, Theresa Dolejsi, MD, Aresa Krasniqi, MD, Elodie Eiffener, MSc, Christa Bongarth, MD, Markus Stühlinger, MD, Martin Huemer, MD, Tommaso Gori, ProfMD, Reza Wakili, ProfMD, Riza Sahin, MD, Robert Schwinger, MD, Matthias Lutz, MD, Armin Luik, MD, Nele Gessler, MD, Peter Clemmensen, ProfMD, Axel Linke, ProfMD, Lars S Maier, ProfMD, Martin Hinterseer, MD, Mathias C Busch, MD, Florian Blaschke, MD, Stefan Sack, ProfMD, Carsten Lennerz, MSc, Manuela Licka, MD, Roland R Tilz, ProfMD, Christian Ukena, MD, Joachim R Ehrlich, ProfMD, Markus Zabel, ProfMD, Georg Schmidt, ProfMD, Ulrich Mansmann, Prof, Stefan Kääb, ProfMD, Konstantinos D Rizas, MD, Steffen Massberg, ProfMD, Andreas May, Peter Seitzer, Roland Schmidt, Dritan Keta, Viktoria Janke, Christian Schläger, Elisabeth André, Niels Brandt, Alexandra Schön, Alfred Zollner, Luisa Freyer, Wolfgang Hamm, Johannes Beil, Anna Katharina Strüven, Anja Loew, Stephanie Fichtner, Philipp Lange, Aresa Krasniqi, Ulrich Grabmeier, Heidi Estner, Philipp Bengel, Lars Lüthje, Aleksandra Kirova, Thomas Fischer, Leonard Bergau, Jonas Herting, Simon Schlögl, Helge Haarmann, Klaudia Schlögl (Illes), Ekrem Uecer, Sabine Sag, Maria Tafelmeier, Carsten Jungbauer, Sabine Fredersdorf-Hahn, Christina Strack, Benedikt Seither, Joachim Seegers, Dominic Millenaar, Jan Wintrich, Patrick Fischer, Axel Buob, Amjad Razouk, Thomas Demming, Johanne Frank, Constantin Kühl, Ulrike Ellendt, Sarah Sandrock, Julia Gänsbacher, Janosch Cupa, Daniel Sinnecker, Karl-Ludwig Laugwitz, Alexander Steger, Anna Berkefeld, Karin Schinke, Petra Barthel, Michael Dommasch, Maiwand Amadei, Gerhard Hindricks, Danilo Obradovic, Michael Döring, Kerstin Bode, Sebastian Hilbert, Susanne Löbe, Helge Knopp, Sebastian König, Silke John, Katharina Schöne, Philipp Hartung, Christian Binner, Christine Meyer-Zürn, Martin Duckheim, Christian Eick, Fabian Simpfle, Jürgen Schreieck, Lars Mizera, Verena Tscholl, Lisa Steinbeck, Nadija Güc, Anne-Sophie Schatz, Philipp Attanasio, Andrea Heuberger, Mattias Roser, Barbara Bellmann, Patrick Nagel, Sebastian Biewener, Saba Suhail, Benjamin Juri, Christian Meyer, Stephan Wiilems, Christiane Jungen, Susanne Schmitt, Paula Münkerer, Julia Vogler, Lukas Kaiser, Benjamin Schäffer, Moritz Nies, Tobias Tönnis, Nina Fluschnik, Hanno Grahn, Christoph Waldeyer, Shinwan Kany, Nils Arne Sörensen, Simon Winkelmann, Özge Akbulak, Nils Arne Gosau, Tilman Würger, Natalie Arnold, Nele Geßler, Alexander Jobs, Paula Münkler, Stefan Rausch, Jelena Köster, Ben Brüggemann, Amr Abdin, Christian Wacker, Philipp Grotherr, Bastian Fries, Maximilian Faust, Stefanie Steuer, Patrick Swojanowsky, Stephan Willems, Nathaniel Portz, Amar Ujeyl, Matthias Krüger, Robert Gramlich, Till Köhler, Armin Sause, Ina Nover, Athanasios-Panagiotis Ziakos, Veaceslav Ciobanu, Norman Spelsberg, Johannes Siebermair, Amir-Abbas Mahabadi, Miriam Köhler, Nadine Vonderlin, Lisa Riesinger, Edison Abdiu, Anja Bachmann, Marie Frenzel, Astrid Hummel, Kristin Lehnert, Anne Krüger, Franke Busse, Andreas Napp, Dirk Müller-Wieland, Simone Battermann, Philipp Lacour, Tobias Trippel, Nick Lasse Beetz, Leonhard Schleußner, Veronika Zach, Christina Rozados, Harald Mudra, Stephan Staubach, Alexander Illmann, Michael Joner, Matthias Bock, Christof Kolb, Tobias Koch, Rebecca Fröhlich, Carsten Lennerz, Tobias Lenz, Patrick Fuchs, Markus Freißmuth, Christian Grebmer, Jürgen Kuschyk, Malte Kranert, Fabian Fastenrath, Gökhan Yücel, Boris Rudic, Sarah Würfel, Albrecht Römer, Andreas Böhmer, Jörg Honold, Stamatis Georgopoulos, Lukas Gleirscher, Susanne Lederle, Artem Chaplygin, Matthias Pauschinger, Andrea Brinker-Paschke, Jana Kropacek, Lars Eckardt, Christian Ellermann, Niklas Bode, Florian Reinke, Hauke Engelke, Robert Höllriegel, Felix Woitek, Ephraim Winzer, Karim Ibrahim, Christian Pflücke, Georg Ende, Uwe Speiser, Stephan Haußig, Rolf Wachter, Tobias Uhe, Torsten Konrad, Edgar Zitron, Jeton Destani, Fangyi Fu, Samer Al Said, Ziya Kaya, Wilfried Schgör, and Thomas Senoner

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Summary: Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. Methods: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36–50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. Findings: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57–73]); left ventricular ejection fraction 45% [40–48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40–11·78]; p

Published
2022
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2. Clinical Heterogeneity in Patients With FOXP3 Mutations Presenting With Permanent Neonatal Diabetes

Author

Amely Cayssials, Mathias Herr, Zdenek Sumnik, Anja Loew, Dorothee Deiss, Sian Ellard, Andrew T. Hattersley, Oscar Rubio-Cabezas, Julian P.H. Shield, Jayne A. L. Minton, Richard Caswell, and Vaughan Lewis

Subjects
Male, medicine.medical_specialty, Pediatrics, Genotype, Endocrinology, Diabetes and Metabolism, Autoimmune enteropathy, medicine.disease_cause, Polymorphism, Single Nucleotide, Infant, Newborn, Diseases, Autoimmune Diseases, Internal medicine, Diabetes mellitus, Molecular genetics, Internal Medicine, medicine, Humans, Enteropathy, Pathophysiology/Complications, Advanced and Specialized Nursing, Chromosomes, Human, X, business.industry, Infant, Newborn, Chromosome Mapping, Infant, Forkhead Transcription Factors, Immune dysregulation, IPEX syndrome, medicine.disease, Pedigree, Diabetes Mellitus, Type 1, Endocrinology, Amino Acid Substitution, Female, business, Nephrotic syndrome
Abstract

OBJECTIVE—Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome is caused by FOXP3 mutations. We aimed to determine the prevalence, genetics, and clinical phenotype of FOXP3 mutations in a large cohort with permanent neonatal diabetes (PNDM). RESEARCH DESIGN AND METHODS—The 11 coding exons and the polyadenylation region of FOXP3 were sequenced in 26 male subjects with diabetes diagnosed before 6 months of age in whom common genetic causes of PNDM had been excluded. Ten subjects had at least one additional immune-related disorder, and the remaining 16 had isolated diabetes. RESULTS—We identified four hemizygous FOXP3 mutations in 6 of 10 patients with associated immune-related disorders and in 0 of 16 patients with isolated diabetes (P = 0.002). Three patients with two novel mutations (R337Q and P339A) and the previously reported L76QfsX53 developed classic IPEX syndrome and died within the first 13 months. The novel mutation V408M was found in three patients from two unrelated families and had a mild phenotype with hypothyroidism and autoimmune enteropathy (n = 2) or nephrotic syndrome (n = 1) and survival to 12–15 years. CONCLUSIONS—FOXP3 mutations result in ∼4% of cases of male patients with permanent diabetes diagnosed before 6 months. Patients not only have classic IPEX syndrome but, unexpectedly, may have a more benign phenotype. FOXP3 sequencing should be performed in any male patient with the diagnosis of diabetes in the first 6 months who develops other possible autoimmune-associated conditions, even in the absence of full IPEX syndrome.

Published
2009

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