Protocol of the Berlin Long-term Observation of Vascular Events (BeLOVE): a prospective cohort study with deep phenotyping and long-term follow up of cardiovascular high-risk patients BMJ Open
Abstract Methods and analysis Patient-reported outcomes Incidental findings management Statistical methods Study implementation, results and modifications to the protocol Discussion Dissemination Code availability Supplementary Material Acknowledgments Footnotes Ethics statements Patient consent for publication References Associated Data Supplementary Materials Abstract Introduction The Berlin Long-term Observation of Vascular Events is a prospective cohort study that aims to improve prediction and disease-overarching mechanistic understanding of cardiovascular (CV) disease progression by comprehensively investigating a high-risk patient population with different organ manifestations. Methods and analysis A total of 8000 adult patients will be recruited who have either suffered an acute CV event (CVE) requiring hospitalisation or who have not experienced a recent acute CVE but are at high CV risk. An initial study examination is performed during the acute treatment phase of the index CVE or after inclusion into the chronic high risk arm. Deep phenotyping is then performed after ~90 days and includes assessments of the patient’s medical history, health status and behaviour, cardiovascular, nutritional, metabolic, and anthropometric parameters, and patient-related outcome measures. Biospecimens are collected for analyses including ‘OMICs’ technologies (e.g., genomics, metabolomics, proteomics). Subcohorts undergo MRI of the brain, heart, lung and kidney, as well as more comprehensive metabolic, neurological and CV examinations. All participants are followed up for up to 10 years to assess clinical outcomes, primarily major adverse CVEs and patient-reported (value-based) outcomes. State-of-the-art clinical research methods, as well as emerging techniques from systems medicine and artificial intelligence, will be used to identify associations between patient characteristics, longitudinal changes and outcomes. Ethics and dissemination The study was approved by the Charité—Universitätsmedizin Berlin ethics committee (EA1/066/17). The results of the study will be disseminated through international peer-reviewed publications and congress presentations. Study registration First study phase: Approved WHO primary register: German Clinical Trials Register: https://drks.de/search/de/trial/DRKS00016852 ; WHO International Clinical Registry Platform: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016852 . Recruitment started on July 18, 2017. Second study phase: Approved WHO primary register: German Clinical Trials Register DRKS00023323, date of registration: November 4, 2020, URL: http://www.drks.de/ DRKS00023323. Recruitment started on January 1, 2021. Keywords: myocardial infarction, heart failure, stroke, acute renal failure, diabetes & endocrinology, risk factors
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Joachim E Weber, Michael Ahmadi, Leif-Hendrik Boldt et al.. Protocol of the Berlin Long-term Observation of Vascular Events (BeLOVE): a prospective cohort study with deep phenotyping and long-term follow up of cardiovascular high-risk patients. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2023-076415 Joachim E Weber, Michael Ahmadi, Leif-Hendrik Boldt, Kai-Uwe Eckardt, Frank Edelmann, Holger Gerhardt, Ulrike Grittner, Kathrin Haubold, Norbert Hübner, Jil Kollmus-Heege, Ulf Landmesser, David M Leistner, Knut Mai, Dominik N Müller, Christian H Nolte, Burkert Pieske, Sophie K Piper, Simrit Rattan, Geraldine Rauch, Sein Schmidt, Kai M Schmidt-Ott, Katharina Schönrath, Jeanette Schulz-Menger, Oliver Schweizerhof, Bob Siegerink, Joachim Spranger, Vasan S Ramachandran, Martin Witzenrath, Matthias Endres, Tobias Pischon
1Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Berlin, Germany 2Department of Neurology, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 3Center for Stroke Research (CSB), Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 4German Center for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany 5Department of Internal Medicine and Cardiology, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 6Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany 7Department of Nephrology and Medical Intensive Care, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 8Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC), Berlin, Germany 9Institute of Biometry and Clinical Epidemiology, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 10Experimental and Clinical Research Center (ECRC), a cooperation of Charité - Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine (MDC), Berlin, Germany 11Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 12Department of Cardiology, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 13Department for Cardiology, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany 14Department of Endocrinology and Metabolism, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 15Center for Cardiovascular Research (CCR), Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 16German Center for Diabetes Research, München-Neuherberg, Germany 17Institute of Medical Informatics, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 18Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany 19Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands 20Sections of Preventive Medicine and Epidemiology, and Cardiovascular Medicine, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA 21Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA 22Division of Pulmonary Inflammation, and Department of Infectious Diseases and Respiratory Medicine, Charité- Universitätsmedizin Berlin, corporate member of the Freie Universität Berlin and Humboldt-Universität Berlin, Berlin, Germany 23German Center for Lung Research (DZL), Germany 24German Center for Neurodegenerative Diseases (DZNE), partner site Berlin, Berlin, Germany 25ExellenceCluster NeuroCure, Berlin, Germany 26Molecular Epidemiology Research Group, Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC), Berlin, Germany 27Biobank Technology Platform, Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC), Berlin, Germany 