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  1. Article

    Open Access

    Author Correction: Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial

    Orly Vardeny, James C. Fang, Akshay S. Desai, Pardeep S. Jhund in Nature Medicine (2023)

  2. Article

    External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial

    The ADA (Age–D-dimer–Albumin) score was developed to identify hospitalized patients at an increased risk for thrombosis in the coronavirus infectious disease-19 (COVID-19) setting. The study aimed to validate ...

    Gerald Chi, Francesco Violi, Pasquale Pignatelli in Journal of Thrombosis and Thrombolysis (2023)

  3. Article

    Open Access

    Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial

    With modern treatments for heart failure with reduced ejection fraction (EF), indicative of impaired cardiac systolic function, patients may exhibit an increase in EF. Limited data are available regarding the ...

    Orly Vardeny, James C. Fang, Akshay S. Desai, Pardeep S. Jhund in Nature Medicine (2022)

  4. Article

    Open Access

    Protein biomarkers of cardiac remodeling and inflammation associated with HFpEF and incident events

    There is increasing evidence that HFpEF is a heterogeneous clinical entity and distinct molecular pathways may contribute to pathophysiology. Leveraging unbiased proteomics to identify novel biomarkers, this s...

    Jessica A. Regan, Lauren K. Truby, Usman A. Tahir, Daniel H. Katz in Scientific Reports (2022)

  5. Article

    Open Access

    Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER

    Whether the sodium–glucose cotransporter 2 inhibitor dapagliflozin reduces the risk of a range of morbidity and mortality outcomes in patients with heart failure regardless of ejection fraction is unknown. A p...

    Pardeep S. Jhund, Toru Kondo, Jawad H. Butt, Kieran F. Docherty in Nature Medicine (2022)

  6. Article

    Open Access

    Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes

    Heart failure with reduced ejection fraction (HFrEF) is increasingly treated with medications for type 2 diabetes mellitus (T2DM). Whether metabolic derangements in HFrEF and T2DM are associated with different...

    Joseph B. Lerman, Stephanie N. Giamberardino, Adrian F. Hernandez in Scientific Reports (2022)

  7. Article

    Open Access

    The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory

    The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare de...

    Emily C. O’Brien, Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson in Trials (2022)

  8. No Access

    Reference Work Entry In depth

    Leveraging “Big Data” for the Design and Execution of Clinical Trials

    Randomized clinical trials form the cornerstone of evidence-based medicine and are required to accurately determine cause-effect relationships and treatment effects of medical interventions. Nonetheless, conte...

    Stephen J. Greene, Marc D. Samsky in Principles and Practice of Clinical Trials (2022)

  9. Article

    Open Access

    The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study

    The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information ...

    Emily C. O’Brien, Sudha R. Raman, Alicia Ellis, Bradley G. Hammill in Trials (2021)

  10. Article

    Open Access

    Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

    There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge.

    Theresa M. Coles, Adrian F. Hernandez in Health and Quality of Life Outcomes (2021)

  11. Article

    Open Access

    Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

    New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional r...

    Guillaume Marquis-Gravel, Holly Robertson, W. Schuyler Jones, Danielle Riley in Trials (2021)

  12. No Access

    Living Reference Work Entry In depth

    Leveraging “Big Data” for the Design and Execution of Clinical Trials

    Randomized clinical trials form the cornerstone of evidence-based medicine and are required to accurately determine cause-effect relationships and treatment effects of medical interventions. Nonetheless, conte...

    Stephen J. Greene, Marc D. Samsky in Principles and Practice of Clinical Trials

  13. No Access

    Article

    A Novel In-hospital Congestion Score to Risk Stratify Patients Admitted for Worsening Heart Failure (from ASCEND-HF)

    Patients hospitalized for heart failure (HF) remain at high risk for early readmission. A post hoc analysis was performed of the biomarker substudy of the ASCEND-HF trial. An in-hospital congestion score was deri...

    Rajeev Masson, Andrew P. Ambrosy in Journal of Cardiovascular Translational Re… (2020)

  14. Article

    Open Access

    Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial

    Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) improve cardiovascular and renal outcomes in patients with type 2 diabetes through distinct mechanism...

    Lindsay E. Clegg, Robert C. Penland, Srinivas Bachina in Cardiovascular Diabetology (2019)

  15. No Access

    Article

    Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy

    To assess the efficacy and safety of betrixaban for venous thromboembolism (VTE) prophylaxis among critically ill patients.

    Gerald Chi, C. Michael Gibson, Arzu Kalayci, Alexander T. Cohen in Intensive Care Medicine (2019)

  16. No Access

    Article

    Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial

    Hospitalized acute medically ill patients with a history of venous thromboembolism (VTE) are at increased risk for recurrent VTE. We characterized the efficacy and safety of betrixaban for prevention of recurr...

    Megan K. Yee, Tarek Nafee, Yazan Daaboul in Journal of Thrombosis and Thrombolysis (2018)

  17. No Access

    Article

    N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy

    Among patients hospitalized with acute heart failure (HF), the prognostic value of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in short-term stroke prediction remains unclear.

    Gerald Chi, James L. Januzzi, Serge Korjian in Journal of Thrombosis and Thrombolysis (2017)

  18. Article

    Open Access

    Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

    The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that ...

    Kevin P. Weinfurt, Adrian F. Hernandez in BMC Medical Research Methodology (2017)

  19. No Access

    Article

    The ADAPTABLE Trial and Aspirin Dosing in Secondary Prevention for Patients with Coronary Artery Disease

    Coronary artery disease (CAD) is the underlying cause of death in one out of seven deaths in the USA. Aspirin therapy has been proven to decrease mortality and major adverse cardiovascular events in patients w...

    Abigail Johnston, W. Schuyler Jones, Adrian F. Hernandez in Current Cardiology Reports (2016)

  20. No Access

    Article

    Role of guanylate cyclase modulators in decompensated heart failure

    In this review we investigate the role of particulate and soluble guanylate cyclase (pGC and sGC, respectively) pathways in heart failure, and several novel drugs that modify guanylate cyclase. Nesiritide and ...

    Veselin Mitrovic, Adrian F. Hernandez, Markus Meyer in Heart Failure Reviews (2009)