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      Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials

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          Abstract

          Aims: Heart failure (HF) affects approximately 26 million people worldwide. With an aging global population, innovative approaches to HF evaluation and management are needed to cope with the worsening HF epidemic. The aim of the Real-Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF) study (NCT03507439) is to evaluate a composite instrument comprising remote, real-time, activity-monitoring devices combined with daily electronic patient-reported outcome (ePRO) items in patients who have been hospitalized for HF and are undergoing standard HF assessment (e.g., 6-min walking distance [6MWD], blood biomarkers, Kansas City Cardiomyopathy Questionnaire [KCCQ], and echocardiography). Methods: REALIsM-HF is an ongoing, 12-week, observational study enrolling 80–100 patients aged ≥45 years with HF with preserved ejection fraction (HFpEF; EF ≥45%) or reduced EF (HFrEF; EF ≤35%). Statistical analyses will include examining the association between data from wearables (the AVIVO<sup>©</sup> mobile patient management patch or VitalPatch<sup>©</sup> biosensor, and the DynaPort MoveMonitor<sup>©</sup>), daily ePROs, and conventional HF metrics (e.g., serum/plasma biomarkers, 6MWD, KCCQ, and echocardiographic parameters). The feasibility of and patient compliance with at-home devices will be documented, and the data captured for the purpose of establishing reference values in patients with HFpEF or HFrEF will be summarized. Conclusions: The REALIsM-HF study is to evaluate the longitudinal daily activity profiles of patients with HF and correlate these with changes in serum/plasma biomarker profiles, symptoms, quality of life, and cardiac function and morphology to inform the use of wearable activity monitors for developing novel therapies and managing patients.

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          Most cited references30

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          Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure.

          B-type natriuretic peptide is released from the cardiac ventricles in response to increased wall tension. We conducted a prospective study of 1586 patients who came to the emergency department with acute dyspnea and whose B-type natriuretic peptide was measured with a bedside assay. The clinical diagnosis of congestive heart failure was adjudicated by two independent cardiologists, who were blinded to the results of the B-type natriuretic peptide assay. The final diagnosis was dyspnea due to congestive heart failure in 744 patients (47 percent), dyspnea due to noncardiac causes in 72 patients with a history of left ventricular dysfunction (5 percent), and no finding of congestive heart failure in 770 patients (49 percent). B-type natriuretic peptide levels by themselves were more accurate than any historical or physical findings or laboratory values in identifying congestive heart failure as the cause of dyspnea. The diagnostic accuracy of B-type natriuretic peptide at a cutoff of 100 pg per milliliter was 83.4 percent. The negative predictive value of B-type natriuretic peptide at levels of less than 50 pg per milliliter was 96 percent. In multiple logistic-regression analysis, measurements of B-type natriuretic peptide added significant independent predictive power to other clinical variables in models predicting which patients had congestive heart failure. Used in conjunction with other clinical information, rapid measurement of B-type natriuretic peptide is useful in establishing or excluding the diagnosis of congestive heart failure in patients with acute dyspnea. Copyright 2002 Massachusetts Medical Society.
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            Heart failure: preventing disease and death worldwide

            Heart failure is a life-threatening disease and addressing it should be considered a global health priority. At present, approximately 26 million people worldwide are living with heart failure. The outlook for such patients is poor, with survival rates worse than those for bowel, breast or prostate cancer. Furthermore, heart failure places great stresses on patients, caregivers and healthcare systems. Demands on healthcare services, in particular, are predicted to increase dramatically over the next decade as patient numbers rise owing to ageing populations, detrimental lifestyle changes and improved survival of those who go on to develop heart failure as the final stage of another disease. It is time to ease the strain on healthcare systems through clear policy initiatives that prioritize heart failure prevention and champion equity of care for all. Despite the burdens that heart failure imposes on society, awareness of the disease is poor. As a result, many premature deaths occur. This is in spite of the fact that most types of heart failure are preventable and that a healthy lifestyle can reduce risk. Even after heart failure has developed, premature deaths could be prevented if people were taught to recognize the symptoms and seek immediate medical attention. Public awareness campaigns focusing on these messages have great potential to improve outcomes for patients with heart failure and ultimately to save lives. Compliance with clinical practice guidelines is also associated with improved outcomes for patients with heart failure. However, in many countries, there is considerable variation in how closely physicians follow guideline recommendations. To promote equity of care, improvements should be encouraged through the use of hospital performance measures and incentives appropriate to the locality. To this end, policies should promote the research required to establish an evidence base for performance measures that reflect improved outcomes for patients. Continuing research is essential if we are to address unmet needs in caring for patients with heart failure. New therapies are required for patients with types of heart failure for which current treatments relieve symptoms but do not address the disease. More affordable therapies are desperately needed in the economically developing world. International collaborative research focusing on the causes and treatment of heart failure worldwide has the potential to benefit tens of millions of people. Change at the policy level has the power to drive improvements in prevention and care that will save lives. It is time to make a difference across the globe by confronting the problem of heart failure.
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              The perindopril in elderly people with chronic heart failure (PEP-CHF) study.

              Many patients who receive a diagnosis of heart failure have neither a low left ventricular (LV) ejection fraction nor valve disease. Few substantial randomized controlled trials have been conducted in this population, none has focussed on patients with evidence of diastolic dysfunction and none has shown clear benefit on symptoms, morbidity, or mortality. This was a randomized double-blind trial, comparing placebo with perindopril, 4 mg/day in patients aged > or =70 years with a diagnosis of heart failure, treated with diuretics and an echocardiogram suggesting diastolic dysfunction and excluding substantial LV systolic dysfunction or valve disease. The primary endpoint was a composite of all-cause mortality and unplanned heart failure related hospitalization with a minimum follow-up of 1 year. A total of 850 patients were randomized. Their mean age was 76 (SD 5) years and 55% were women. Median follow-up was 2.1 (IQR 1.5-2.8) years. Enrollment and event rates were lower than anticipated, reducing the power of the study to show a difference in the primary endpoint to 35%. Many patients withdrew from perindopril (28%) and placebo (26%) after 1 year and started taking open-label ACE-inhibitors. Overall, 107 patients assigned to placebo and 100 assigned to perindopril reached the primary endpoint (HR 0.919: 95% CI 0.700-1.208; P = 0.545). By 1 year, reductions in the primary outcome (HR 0.692: 95% CI 0.474-1.010; P = 0.055) and hospitalization for heart failure (HR 0.628: 95% CI 0.408-0.966; P = 0.033) were observed and functional class (P < 0.030) and 6-min corridor walk distance (P = 0.011) had improved in those assigned to perindopril. Uncertainty remains about the effects of perindopril on long-term morbidity and mortality in this clinical setting since this study had insufficient power for its primary endpoint. However, improved symptoms and exercise capacity and fewer hospitalizations for heart failure in the first year were observed on perindopril, during which most patients were on assigned therapy, suggesting that it may be of benefit in this patient population.
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                Author and article information

                Journal
                DIB
                DIB
                10.1159/issn.2504-110X
                Digital Biomarkers
                S. Karger AG
                2504-110X
                2020
                May – August 2020
                30 June 2020
                : 4
                : 2
                : 45-59
                Affiliations
                [_a] aBayer AG, Medical Devices & eHealth Clinical, Wuppertal, Germany
                [_b] bDepartment of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA
                [_c] cNorthwestern University, Feinberg School of Medicine, Chicago, Illinois, USA
                [_d] dDivision of Cardiology, Pulmonary Diseases and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany
                [_e] eCardiology Department, University and Spedali Civili of Brescia, Brescia, Italy
                [_f] fDepartment of Cardiology, Heart Center at the University Hospital Cologne and Cologne Cardiovascular Research Center, Cologne, Germany
                [_g] gDivision of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy
                [_h] hBayer AG, Health Economics and Outcomes Research, Wuppertal, Germany
                [_i] iBayer AG, Clinical Sciences Data Management, Wuppertal, Germany
                [_j] jBayer US, LLC, Bayer HealthCare Pharmaceuticals Inc., Global Clinical Information and Analytics, Data Acquisition Technology Integration, Whippany, New Jersey, USA
                [_k] kBayer Business Services GmbH, IT BP Pharmaceuticals, Clinical, Wuppertal, Germany
                [_l] lBayer AG, Translational Studies Operations, Wuppertal, Germany
                [_m] mBayer US, LLC, Bayer HealthCare Pharmaceuticals Inc., Global Project Management, Whippany, New Jersey, USA
                [_n] nBayer AG, Research and Early Development Statistics, Berlin, Germany
                [_o] oBayer AG, Medical Experts Cardiology and Coagulation, Wuppertal, Germany
                [_p] pGlobal Customer Success Team, SAP Health, SAP SE, Walldorf, Germany
                [_q] qSAP AG, SAP Digital Business Services – EMEA, SAP Deutschland SE & Co. KG, Walldorf, Germany
                [_r] rMedtronic, Mounds View, Minneapolis, Minnesota, USA
                [_s] sMcRoberts B.V., The Hague, The Netherlands
                [_t] tsovanta AG, Heidelberg, Germany
                [_u] uGwaltney Consulting, Westerly, Rhode Island, USA
                [_v] vHuawei Technologies Deutschland GmbH, Düsseldorf, Germany
                [_w] wMedical Department, Division of Cardiology, Charité Campus Virchow Clinic, Berlin University of Medicine, Berlin, Germany
                [_x] xBayer AG, Experimental Medicine Cardiovascular/Hematology, Wuppertal, Germany
                Author notes
                *Frank Kramer, Bayer AG, Medical Devices &amp; eHealth Clinical, Aprather Weg 18a, DE–42133 Wuppertal (Germany), frank.kramer@bayer.com
                Article
                507696 Digit Biomark 2020;4:45–59
                10.1159/000507696
                33083685
                538f0beb-b511-4928-b173-97508e6e1529
                © 2020 The Author(s) Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 18 December 2019
                : 01 April 2020
                Page count
                Figures: 3, Tables: 3, Pages: 15
                Categories
                Further Section

                Oncology & Radiotherapy,Geriatric medicine,Cardiovascular Medicine,Clinical Psychology & Psychiatry,Public health
                Activity monitors,Patient-reported outcomes,Wearables,Heart failure,Biomarker

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