Bibliography

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    1. O’Connor CM, Psotka MA, Fiuzat M, Lindenfeld J, Abraham WT, Bristow MR, Canos D, Harrington RA, Hillebrenner M, Jessup M, Malik FI, Solomon SD, Stockbridge N, Tcheng JE, Unger EF, Whellan DJ, Zuckerman B, Califf RM. Improving Heart Failure Therapeutics Development in the United States.J Am Coll Cardiol. 2018; 71(4): 443-453.
    2. O’Connor CM, Bristow MR. Changing the Research Culture in the United States.J Am Coll Cardiol HF. 2018 Apr; 6(4): 344-345.
    3. Tahhan AS, Vaduganathan M, Greene SJ, Fonarow GC, Fiuzat M, Jessup M, Lindenfeld J, O’Connor CM, Butler J. Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials.JAMA Cardiol. 2018 Oct; 3(10): 1011-1019.
    4. Butler J, Packer M, Greene SJ, Fiuzat M, Anker SD, Anstrom KJ, Carson PE, Cooper LB, Fonarow GC, Hernandez AF, Januzzi JL, Jessup M, Kalyani RR, Kaul S, Kosiborod M, Lindenfeld J, McGuire DK, Sabatine MS, Solomon SD, Teerlink JR, Vaduganathan M, Yancy CW, Stockbridge N, O’Connor CM. Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Transporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus.Circ Heart Fail. 2019 Dec 17; 140(25): 2108-2118.
    5. Psotka MA, Fiuzat M, Carson PE, Kao DP, Cerkvenik J, Verta P, Kazmierski, Shinnar M, Stockbridge N, Unger EF, Zuckerman B, Butler J, Felker GM, Konstam MA, Lindenfeld J, Solomon SD, Teerlink JR, O’Connor CM, Abraham WT. Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development.J Am Coll Cardiol HF. 2019 Nov; 7(11): 913-921.
    6. Abraham WT, Psotka MA, Fiuzat M, Filippatos G, Lindenfeld J, Mehran R, Ambardekar AV, Carson PE, Jacob R, Januzzi JL, Konstam MA, Krucoff MW, Lewis EF, Piccini JP, Solomon SD, Stockbridge N, Teerlink JR, Unger EF, Zeitler EP, Anker SD, O’Connor CM. Standardized Definitions of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium. J Am Coll Cardiol HF. 2020 Dec; 8(12): 961-972.
    7. Abraham WT, Fiuzat M, Psotka MA, O’Connor CM. Heart Failure Collaboratory Statement on Clinical Trials in the Landscape of COVID-19. J Am Coll Cardiol HF. 2020 May; 8(5): 423-425.
    8. Fiuzat M, Lowy N, Stockbridge N, Sbolli M, Latta F, Lindenfeld J, Lewis EF, Abraham WT, Teerlink J, Walsh M, Heidenreich P, Bozkurt B, Starling RC, Solomon S, Felker GM, Butler J, Yancy C, Stevenson LW, O’Connor C, Unger E, Temple R, McMurray J. Endpoints in Heart Failure Drug Development: History and Future. J Am Coll Cardiol HF. 2020 Jun; 8(6): 429-440.
    9. Psotka MA, Latta F, Cani D, Fiuzat M, Sbolli M, Barnett S, Metra M, O’Connor CM. Publication Rates of Heart Failure Clinical Trials Remain Low. J Am Coll Cardiol. 2020;75(25):3151-3161. doi:10.1016/j.jacc.2020.04.068
    10. O’Connor CM, Bristow MR. Changing U.S. Heart Failure Research Culture: Part 2–Recognizing Frontline Investigators and Coordinators. J Am Coll Cardiol HF. 2020 Dec; 8(12): 1050-1051.
    11. Perego C, Sbolli M, Specchia C, Fiuzat M, McCaw ZR, Metra M, Oriecuia G, Wei L, O’Connor CM, Psotka MA. Utility of Restricted Mean Survival Time Analysis for Heart Failure Clinical Trial Evaluation and Interpretation. J Am Coll Cardiol HF. 2020 Dec; 8(12): 973-983.
    12. Psotka MA, Abraham WT, Fiuzat M, Filippatos G, Lindenfeld J, Ahmad T, Bhatt A, Carson PE, Cleland JGF, Felker GM, Januzzi JL, Kitzman DW, Leifer ES, Lewis EF, McMurray JJV, Mentz RJ, Solomon SD, Stockbridge N, Teerlink JR, Vaduganathan M, Vardeny O, Whellan DJ, Wittes J, Anker SD, O’Connor CM. Conduct of Clinical Trials in the Era of COVID-19: JACC Scietific Expert Panel. J Am Coll Cardiol. 2020 Nov 17; 76(20): 2368-2378.
    13. Psotka MA, Fiuzat M, Solomon SD, Chauhan C, Felker GM, Butler J, Teerlink JR, Sinha SS, O’Connor CM, Konstam MA. Challenges and Potential Improvements to Patient Access to Pharmaceuticals. Circ Heart Fail. 2020 Aug 25; 142(8): 790-798.
    14. Reza N, Tahhan AS, Mahmud N, DeFilippis EM, Alrohaibani A, Vaduganathan M, Greene SJ, Ho AH, Fonarow GC, Butler J, O’Connor C, Fiuzat M, Vardeny O, Piña IL, Lindenfeld J, Jessup M. Representation of Woman Authors in International Heart Failure Guidelines and Contemporary Clinical Trials. Circ Heart Fail. 2020 Aug 6; 13(8): e006605.
    15. Sinha SS, Psotka MA, Fiuzat M, Barnett SD, Bruckmann M, Butler J, DeSouza MM, Felker GM, Solomon SD, Stockbridge N, Teerlink JR, Unger EF, O’Connor CM, Konstam MA. Barriers to Clinical Trial Efficacy and Patient Access: The Heart Failure Collaboratory Industry Survey. medRxiv. 2020 Aug: 2020-06.
    16. Anchouche K, Elharram M, Oulousian E, Razaghizad A, Avram R, Marquis-Gravel G, Randhawa VK, Nkulikiyinka R, Ni W, Fiuzat M, O’Connor C, Psotka MA, Fox J, Tyl B, Kao D, Sharma A. Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review. Can J Cardiol. 2021 Sep; 37(9): 1438-1449.
    17. Bhatt AS, Abraham WT, Lindenfeld J, Bristow M, Carson PE, Felker GM, Fonarow GC, Greene SJ, Psotka MA, Solomon SD, Stockbridge N, Teerlink JR, Vaduganathan M, Wittes J, Fiuzat M, O’Connor CM, Butler J. Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory. J Am Coll Cardiol HF.2021 Jan; 9(1): 1-12.
    18. Bhatt AS, Jering KS, Vaduganathan M, Claggett BL, Cunningham JW, Rosenthal N, Signorovitch J, Thune JJ, Vardeny O, Solomon SD. Clinical Outcomes in Patients With Heart Failure Hospitalized with COVID-19. J Am Coll Cardiol HF. 2021 Jan; 9(1): 65-73.
    19. DeFilippis EM, Fiuzat M. Putting the “Optimal” in Optimal Medical Therapy. J Am Coll Cardiol HF. 2021 Jan; 9(1): 39-41.
    20. Lindenfeld J, Fiuzat M, O’Connor C. Promoting Diversity in Clinical Trial Leadership: A Call to Action. J Am Coll Cardiol HF. 2021 May; 9(5): 401-402.
    21. Butt JH, Dewan P, DeFilippis EM, Biering-Sørensen T, Docherty KF, Jhund PS, Kosiborod MN, Martinez FA, Bengtsson O, Johansen ND, Langkilde AM, Sjöstrand M, Vaduganathan M, Solomon SD, Sabatine MS, Køber L, Fiuzat M, McMurray JJV. Effects of Dapagliflozin According to the Heart Failure Collaboratory Medical Therapy Score: Insights from DAPA-HF. J Am Coll Cardiol HF. 2022 Aug 10 (8) 543-555.
    22. DeFilippis EM, Echols M, Adamson PB, Batchelor WB, Cooper LB, Cooper LS, Desvigne-Nickens P, George RT, Ibrahim NE, Jessup M, Kitzman DW, Leifer ES, Mendoza M, Piña IL, Psotka M, Senatore FF, Stein KM, Teerlink JR, Yancy CW, Lindenfeld J, Fiuzat M, O’Connor CM, Vardeny O, Vaduganathan M. Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory. JAMA Cardiol. 2022 Mar 23; 7(5): 540-548.
    23. Fiuzat M, Hamo CE, Bulter J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O’Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8; 79(5): 504-510.
    24. Lala A, O’Connor CM, Fiuzat M, Drazner MH, Mentz RJ. Recognizing Effort that Support Clinical Trial Success: Site-Based Research Awards from the Heart Failure Collaboratory and Heart Failure Society of America. Journal of Cardiac Failure. 2022; 28(9): 1387-1389.
    25. Ostrominski JW, Hirji S, Bhatt AS, Butler J, Fiuzat M, Fonarow GC, Heidenreich PA, Januzzi JL, Lam CSP, Maddox TM, O’Connor CM, Vaduganathan M. Cost and Value in Contemporary Heart Failure Clinical Guidance Documents. J Am Coll Cardiol HF. 2022 Jan; 10(1): 1-11.
    26. Psotka MA, Abraham WT, Fiuzat M, Filippatos G, Lindenfeld J, Ahmad T, Felker GM, Jacob R, Kitzman DW, Leifer ES, Lewis EF, Mentz RJ, Nkulikiyinka R, Ni W, Schaber DE, Sharma A, Solomon SD, Stockbridge N, Teerlink JR, Unger EF, Whellan DJ, Wittes J, Anker SD, O’Connor CM. Functional and Symptomatic Endpoints: The HFC-ARC Scientific Expert Panel. J Am Coll Cardiol HF. 2022 Dec; 10(12): 889-901.
    27. Bhatt AS, Dimond M, Fiuzat M, Vardeny O, Divanji P, Komtebedde J, Lefkowitz MP, Nkulikiyinka R, Petersson M, Roessig L, Schaber D, O’Connor CM, Solomon SD. Impact of COVID-19 on Heart Failure Clinical Trials: Insights From the Heart Failure Collaboratory. J Am Coll Cardiol HF. 2023 Feb 6; 11(2): 254-257.
    28. Dimond MG, Fiuzat M, Mentz RJ, Lala-Trindade A, Whellan DJ, Walsh MN, Costanzo MR, Yehya A, Desvigne-Nickens P, Malik F, O’Connor CM, Bristow MR. Rewarding Site-Based Research: A Step Towards Improving the Ecosystem of Heart Failure Clinical Trials. J Am Coll Cardiol HF. 2023
    29. Johansen ND, Vaduganathan M, Zahir D, Fiuzat M, DeFilippis EM, Januzzi JL, Butler J, O’Connor CM, Abraham WT, Psotka MA, McMurray JJV, Dewan P, Claggett BL, Solomon SD, Modin D, Butt JH, Jensen JUS, Schou M, Torp-Pedersen C, Køber L, Gislason GH, Biering-Sørensen T. A Composite Score Summarizing Use and Dosing of Evidence-Based Medical Therapies in Heart Failure: A Nationwide Cohort Study. Circ Heart Fail. 2023 Jan 25; 16(2)
    30. Yehya A. Recognizing Physicians Beyond Revenue Value Units. J Card Fail. 2023 Sep 29: S2071-9164(23)00340-8. 
    31. Psotka M. Step by Step: Really Need It in Our World∗ . J Am Coll Cardiol HF. 2023 Nov, 11 (11) 1531–1533.
    32. Lala A, Hamo C, Bozkurt B, Fiuzat M, Blumer V, Bukhoff D, Butler J, Costanzo MR, Felker MG, Filippatos G, Konstam MA, McMurray JJV, Mentz RJ, Metra M,  Psotka MA, Solomon SD, Teerlink J, Abraham WT, O’Connor CM. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper. J Am Coll Cardiol HF. 2024 Jan, 12 (1) 1–15.
    33. Blumer V, Bogaev R, Fiuzat M. Sex Diversity in Heart Failure Clinical Trials: Actions Speak Louder Than Words∗ . J Am Coll Cardiol Adv. 2024 Jan, 3 (1).
    34. Dimond MG, Ibrahim NE, Fiuzat M, McMurray JJV, Lindenfeld J, Ahmad T, Bozkurt B, Bristow MR, Butler J, Carson PE, Felker GM, Jessup M, Murillo J, Kondo T, Solomon SD, Abraham WT, O’Connor CM, Psotka MA. (2023). Left Ventricular Ejection Fraction and the Future of Heart Failure Phenotyping. JACC Heart Fail. 2024;12(3):451-460. doi:10.1016/j.jchf.2023.11.005
    35. Adamson PB, Echols M, DeFilippis EM, Morris AA, Bennett M, Abraham WT, Lindenfeld J, Teerlink JR, O’Connor CM, Connolly AT, Li H, Fiuzat M, Vaduganathan M, Vardeny O, Batchelor W, McCants KC, & Heart Failure Collaboratory.Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations. JACC Heart Fail. 2024;12(7):1212-1222. doi:10.1016/j.jchf.2024.02.015
    36. Fleming TR, Wittes J, Fiuzat M, Bristow MR, Rockhold FW, Connor JT, Saville BR, Claggett B, Cavagna I, Abraham WT, Cook TD, Lindenfeld J, O’Connor C, DeMets DL, & Heart Failure Collaboratory (2024). Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory. JACC Heart Fail. 2024;12(8):1317-1327. doi:10.1016/j.jchf.2024.02.016
    37. Bhatt AS, Fiuzat M. How Did We Score? Evaluating the Utility of a Score-Based System for Heart Failure Medical Therapy. Circ Heart Fail. 2024;17(5):e011654. doi:10.1161/CIRCHEARTFAILURE.124.011654
    38. Blumer V, Januzzi JL Jr, Lindenfeld J, et al. Heart Failure Drug Development Over the Eras: From the Heart Failure Collaboratory. JACC Heart Fail. 2024 Jun 26:S2213-1779(24)00416-5.
    39. Rao VN, Hellkamp AS, Thomas LE, et al. Optimal Medical Therapy and Outcomes Among Patients With Chronic Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2024 Jul 25:S2213-1779(24)00498-0.
    40. Bhatt AS, Chatur S, Claggett BL, et al. Gamified Behavioral Science Intervention to Enhance Trial Enrollment: An Embedded Study Within the FINEARTS-HF Trial. JACC Heart Fail. 2024 May 11:S2213-1779(24)00399-8.
    41. Reza N, Fiuzat M, Konstam MA. Measures to Improve Trial Enrollment: It’s Game Time!. JACC Heart Fail. 2024 Aug 29:S2213-1779(24)00605-X.
    42. Cunningham JW, Abraham WT, Bhatt AS, Dunn J, Felker GM, Jain SS, Lindsell CJ, Mace M, Martyn T, Shah RU, Tison GH, Fakhouri T, Psotka MA, Krumholz H, Fiuzat M, O’Connor CM, Solomon SD; Heart Failure Collaboratory. Artificial Intelligence in Cardiovascular Clinical Trials. J Am Coll Cardiol. 2024;84(20):2051-2062.
    43. Evans Y, Fiuzat M, Jessup M, Bristow MR, Sweitzer NK, O’Connor C.; Rewarding Site-Based Research: The Unsung Heroes of Heart Failure Clinical Research. Circ Heart Fail. 2024;17(11):e012481. doi:10.1161/CIRCHEARTFAILURE.124.012481
    44. Shalowitz EL, Jhund PS, Psotka MA, Sharma A, Dimond MG, Martyn T, Nkulikiyinka R, Fiuzat M, Kao DP. Where’s the Remote? Failure to Report Clinical Workflows in Heart Failure Remote Monitoring Studies. J Card Fail. 2024 Dec 16:S1071-9164(24)00967-9. doi: 10.1016/j.cardfail.2024.11.012. Epub ahead of print. PMID: 39694453.
    45. Lala A, Coca S, Feinman J, Hamo CE, Fiuzat M, Abraham WT, O’Connor C, Lindenfeld J, Januzzi J, Cavagna I, Teerlink JR, Sarnak MJ, Parikh CR, McCallum W, Konstam MA, Costanzo MR. Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure: JACC Expert Panel From the HF-ARC. J Am Coll Cardiol. 2025 Feb 25;85(7):766-781.
    46. Fiuzat M, Ferlin K, Gottschalk L, Farb A, Cavagna I, Lindenfeld J, Zuckerman B, Kelly D; Heart Failure Collaboratory. An Innovative Program for Evidence Generation: HFC Perspective on the FDA Total Product Life Cycle Advisory Program. JACC Heart Fail. 2025 Feb 26:S2213-1779(25)00147-7.
    47. Cavagna I, Fiuzat M, Lala A, Januzzi J, Abraham W, Dimond M, Konstam M, O’Connor C, Costanzo MR; Heart Failure Collaboratory. Inertia Is Not an Option: Laying the Foundation for a Consensus on the Assessment of Kidney Function in Acute Decompensated Heart Failure. J Card Fail. 2025 Feb 25:S1071-9164(25)00093-4.
    48. Cunningham JW, O’Connor CM. The Future of Artificial Intelligence-Assisted Event Adjudication. JACC Heart Fail. 2025;13(5):722-724. 
    49. Butler J, Usman MS, Gandotra C, Salman A, Farb A, Thompson AM, Stockbridge N, Zeller C, Folkvaljon F. Patient-Reported Outcomes as End Points in Heart Failure Trials. Circulation. 2025 Apr 15;151(15):1111-1125. 
    50. Mann DL, Felker GM, Unger EF, Wittes JT, Bozkurt B, Malik FI, Stockbridge N, Saville BR, Fiuzat M, O’Connor CM, Solomon SD. Derisking Phase II Clinical Trials in Heart Failure: A Position Paper from JACC: Basic to Translational Science and the Heart Failure Collaboratory. JACC Basic Transl Sci. 2025 May;10(5):677-688. 
    51. Leifer ES, Troendle JF, Psotka MA, Sachdev V. Hierarchical Analysis of Composite Time-to-Event End Points in Heart Failure Clinical Trials Using Time in Clinical State. Circulation: Heart Failure. 2025 May 15;8(7):e011783.
    52. DeFilippis EM, Blumer V, Makuvire TT, Echols MR, Adamson PB, Solomon S, Pina IL, Stein KM, Vaduganathan M, Walsh MN, Vardeny O, Jessup M, Yancy CW, Lindenfeld J, O’Connor CM, Fiuzat M. Social Drivers of Health in Heart Failure Trials: An Analysis From the Heart Failure Collaboratory. JACC: Heart Failure. 2025 July 20;13(9).
    53. Fiuzat M, Butler J, Stockbridge M, Lindenfeld J, Cavagna I, O’Connor C. Background Therapy for HF Clinical Trials: A Randomized Crossover Debate from the Heart Failure Collaboratory. JACC: Heart Failure. 2025 October;13(10):102596.
    54. Armbruster S, McCam ZR, Jering K, Claggett BL, Vaduganathan M, Solomon S, Pfeffer MA, Wei LJ. Capturing Totality of Treatment Effects: A Model-Free Approach to Analyzing Multiple Event-Time Data From Heart Failure Studies. JACC: Heart Failure. 2025 October; 13(10):102605.
    55. Blumer V, Lindenfeld J, Lala A, Carson P, Chapman RB, Fiuzat M, O’Connor C, Krantz MJ. Let Us Call It Cardiogenic Preshock: A Working Definition From the Heart Failure Collaboratory. JACC. 2025 Sept 16;86(11):832-835.
    56. Bhatt AS, De Oliveira-Gomes D, Fiuzat M, Vaduganthan M, Hamo CE, Stockbridge N, Butler J, Psotka M, Abraham WT, McGuire DK, Martyn T, Greenberg BH, O’Connor C, Solomon SD. Assessing Medical Therapy Optimization in Cardiovascular-Kidney-Metabolic Clinical Trials: An Initiative From the Heart Failure Collaboratory. JACC: Heart Failure. 2025 Oct 29;102727. 
    57. Rivera AD, Fiuzat M, Bristow MR, Sweitzer NK, O’Connor CM. Backbone of Trials in a Challenging Environment: Recognizing Site-Based Research Teams. Circulation: Heart Failure. 2025 Nov 9.
    58. Kose O, Sahal A, Zhang GK, Possik E, Fiuzat M, Psotka MA, Kao DP, Shalowitz E, Martyn T, Kittipibul V, Ni W, Tingley W, Vlajnic V, Abildstrøm SZ, Cowie M, Majmudar, Ahmad T, Leifer E, Fudim M, O’Connor CM, Sharma A. Framework for Analytical Validation of DHT-Based Actigraphy and Signal Measures in HF Trials: The VALIDATE-HF Program. JACC: Heart Failure. 2025 Dec 11: 102831.
    59. Blumer V, Bozkurt B, Konstam MA, Fiuzat M, Abraham WT, Bristow MR, Cavagna I, Cedars A, Greenberg B, Guilliod C, Ho C, Januzzi J, Lala A, Maurer MS, McMurray JJV, Psotka MA, Saville BR, Solomon SD, Wittes J, Lindenfeld J, O’Connor C. Subgroups and Special Populations in Heart Failure Clinical Trials: Insights From the HFC-ARC Expert Consensus Panel. JACC: Heart Failure. 2026 Jan 5: 102775.
    60. Shalowitz EL, Jhund P, Psotka MA, Sharma A, Dimond M, Martyn T, Cowie M, Moayedi Y, Hawkins NM, Ezekowitz J, Amir O, Volterrani M, Fiuzat M, O’Connor C, Kao DP. Standardized Reporting in Heart Failure Noninvasive Remote Monitoring Trials: Interventions to Catalyze Data Into Action. JACC: Heart Failure. 2026 Jan 23: 102849.
    61. Krantz MJ, Sentatore F, Psotka MA, Fiuzat M, Southworth MR, Stockbridge N. Heart Failure Endpoints in FDA Pivotal Trials. European Heart Journal. 2026 Jan 30: ehag069.
    62. Fiuzat M, O’Connor C, Mann DL. In Memoriam: Micheal R. Bristow, MD, PhD. Journal of Cardiac Failure. 2026 Feb 10.
    63. McCallum W, Tighiouart M, Tuttle M, Oka T, Testani JM, Udelson JE, Bautista I, Lala A, Rosa Costanzo M, O’Connor CM, Fiuzat M, Konstam MA, Sarnak MJ. Association of the Tming of Acute Declines in Kidney Function in Acute Heart Failure With Cardiovascular and Kidney Outcomes. American Journal of Kidney Diseases. 2026 Mar 23.
    64. Batchelor WB, Califf R, Mehran R, Stone G, Blumer V, O’Connor C, Sharma G, Fiuzat M, Douglas P, Coylewright M, Yancy CW, Baron SJ, Kandzari DE, Abbott JD, Echols MR, Rymer JA, Krucoff MW, Spitzer E, Damluji AA. Aligning Coronary Stent Trial Enrollment With the U.S. Intended-Use Population: Implications of Site Selection. JACC. 2026 Apr 28:87(16):2163-2176.