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1. Framework of the strengths and challenges of clinically integrated trials: An expert panel report

Author

Peters, Anthony E., Jones, W. Schuyler, Anderson, Brian, Bramante, Carolyn T., Broedl, Uli, Hornik, Christoph P., Kehoe, Lindsay, Knowlton, Kirk U., Krofah, Esther, Landray, Martin, Locke, Trevan, Patel, Manesh R., Psotka, Mitchell, Rockhold, Frank W., Roessig, Lothar, Rothman, Russell L., Schofield, Lesley, Stockbridge, Norman, Trontell, Anne, Curtis, Lesley H., Tenaerts, Pamela, and Hernandez, Adrian F.

Published
2024
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3. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials JACC Review Topic of the Week

Author

Fiuzat, Mona, Hamo, Carine E, Butler, Javed, Abraham, William T, DeFilippis, Ersilia M, Fonarow, Gregg C, Lindenfeld, Joann, Mentz, Robert J, Psotka, Mitchell A, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Vardeny, Orly, McMurray, John JV, and O’Connor, Christopher M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Heart Disease, Cardiovascular, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cardiovascular Agents, Clinical Trials as Topic, Heart Failure, Humans, Periodicals as Topic, Stroke Volume, clinical trials, device therapy, drug therapy, FDA, guideline directed, medical therapy, heart failure, HFrEF, medication, guideline directed medical therapy, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.

Published
2022

7. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

Author

Lala, Anuradha, Hamo, Carine E., Bozkurt, Biykem, Fiuzat, Mona, Blumer, Vanessa, Bukhoff, Daniel, Butler, Javed, Costanzo, Maria Rosa, Felker, G. Michael, Filippatos, Gerasimos, Konstam, Marvin A., McMurray, John J.V., Mentz, Robert J., Metra, Marco, Psotka, Mitchell A., Solomon, Scott D., Teerlink, John, Abraham, William T., and O’Connor, Christopher M.

Published
2024
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8. Sex-Related Differences in Patient Characteristics, Hemodynamics, and Outcomes of Cardiogenic Shock: INOVA-SHOCK Registry

Author

Epps, Kelly C., Tehrani, Behnam N., Rosner, Carolyn, Bagchi, Pramita, Cotugno, Annunziata, Damluji, Abdulla A., deFilippi, Christopher, Desai, Shashank, Ibrahim, Nasrien, Psotka, Mitchell, Raja, Anika, Sherwood, Matthew W., Singh, Ramesh, Sinha, Shashank S., Tang, Daniel, Truesdell, Alexander G., O’Connor, Christopher, and Batchelor, Wayne

Published
2023
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9. Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Author

Dimond, Matthew, Khan, Mohammad S, Fiuzat, Mona, Cleland, John G, Bhatt, Ankeet, Psotka, Mitchell, Anker, Stefan D, Butler, Javed, Felker, Michael, Mark, Daniel B, Carson, Peter E, Abraham, William T, Ahmad, Tariq, Lindenfeld, Joann, Vaduganathan, Muthiah, Whellan, David J, Vardeny, Orly, Solomon, Scott, Lewis, Eldrin F, Filippatos, Gerasimos, and OConnor, Christopher M

Published
2023
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11. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Felker, G. Michael, Jacob, Richard, Kitzman, Dalane W., Leifer, Eric S., Lewis, Eldrin F., Mentz, Robert J., Nkulikiyinka, Richard, Ni, Wei, Schaber, Daniel E., Sharma, Abhinav, Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Whellan, David J., Wittes, Janet, Anker, Stefan D., and O’Connor, Christopher M.

Published
2022
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13. Why has positive inotropy failed in chronic heart failure? Lessons from prior inotrope trials

Author

Ahmad, Tariq, Miller, P Elliott, McCullough, Megan, Desai, Nihar R, Riello, Ralph, Psotka, Mitchell, Böhm, Michael, Allen, Larry A, Teerlink, John R, Rosano, Giuseppe MC, and Lindenfeld, Joann

Subjects
Heart Disease, Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Cardiotonic Agents, Chronic Disease, Clinical Trials as Topic, Exercise Tolerance, Heart Failure, Hemodynamics, Humans, Mortality, Myocardial Contraction, Quality of Life, Stroke Volume, Treatment Failure, Chronic heart failure, Inotropes, Clinical trials, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

Current pharmacological therapies for heart failure with reduced ejection fraction are largely either repurposed anti-hypertensives that blunt overactivation of the neurohormonal system or diuretics that decrease congestion. However, they do not address the symptoms of heart failure that result from reductions in cardiac output and reserve. Over the last few decades, numerous attempts have been made to develop and test positive cardiac inotropes that improve cardiac haemodynamics. However, definitive clinical trials have failed to show a survival benefit. As a result, no positive inotrope is currently approved for long-term use in heart failure. The focus of this state-of-the-art review is to revisit prior clinical trials and to understand the causes for their findings. Using the learnings from those experiences, we propose a framework for future trials of such agents that maximizes their potential for success. This includes enriching the trials with patients who are most likely to derive benefit, using biomarkers and imaging in trial design and execution, evaluating efficacy based on a wider range of intermediate phenotypes, and collecting detailed data on functional status and quality of life. With a rapidly growing population of patients with advanced heart failure, the epidemiologic insignificance of heart transplantation as a therapeutic intervention, and both the cost and morbidity associated with ventricular assist devices, there is an enormous potential for positive inotropic therapies to impact the outcomes that matter most to patients.

Published
2019

14. Heart Failure Site-Based Research in the United States Results of the Heart Failure Society of America Research Network Survey

Author

Psotka, Mitchell A, Ammon, Susan E, Fiuzat, Mona, Bozkurt, Biykem, Chung, Eugene S, Cole, Robert T, Greene, Stephen J, Kraus, David, Ky, Bonnie, McIlvennan, Colleen K, Shah, Palak, Teerlink, John R, Walsh, Mary Norine, Jessup, Mariell, and O'Connor, Christopher M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Heart Disease, Clinical Trials and Supportive Activities, Clinical Research, Academic Medical Centers, Biomedical Research, Clinical Trials as Topic, Contracts, Cross-Sectional Studies, Ethics Committees, Research, Heart Failure, Humans, Nurse Practitioners, Nurses, Patient Selection, Physicians, Research Personnel, Research Support as Topic, Societies, Medical, Surveys and Questionnaires, Time Factors, United States, clinical trials, heart failure clinical research, research network, site-based research, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThis study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States.BackgroundImprovements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the United States are needed in order to enhance efficiency and impact.MethodsThe Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity for the purpose of understanding the barriers that exist to conducting high-quality HF clinical research.ResultsOverall, 1,794 HFSA members were queried, and 434 members (24%) completed surveys, whereas a total of 7,589 individuals with interest in HF were queried, and 615 completed surveys. Of the respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents, 270, were physicians (44%); 311 of the total (76% of the total and 80% of physicians) practiced in academic institutions; 333 respondents (81%) had served as principal investigators and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1 to 5 trials and enrolled 1 to 20 patients annually. Institutional review board (IRB) approval typically required 3 months, and contract completion required 3 to 6 months per site. The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators.ConclusionsMany U.S. clinical research sites are constrained by budgetary, staffing, and contractual issues. The HFSA Research Network seeks to unify interested sites and deconstruct barriers to permit high-value HF research.

Published
2019

15. A Standardized and Regionalized Network of Care for Cardiogenic Shock

Author

Tehrani, Behnam N., Sherwood, Matthew W., Rosner, Carolyn, Truesdell, Alexander G., Ben Lee, Seiyon, Damluji, Abdulla A., Desai, Mehul, Desai, Shashank, Epps, Kelly C., Flanagan, Michael C., Howard, Edward, Ibrahim, Nasrien, Kennedy, Jamie, Moukhachen, Hala, Psotka, Mitchell, Raja, Anika, Saeed, Ibrahim, Shah, Palak, Singh, Ramesh, Sinha, Shashank S., Tang, Daniel, Welch, Timothy, Young, Karl, deFilippi, Christopher R., Speir, Alan, O’Connor, Christopher M., and Batchelor, Wayne B.

Published
2022
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16. Effect of Torsemide Versus Furosemide on Symptoms and Quality of Life Among Patients Hospitalized for Heart Failure: The TRANSFORM-HF Randomized Clinical Trial

Author

Greene, Stephen J., Velazquez, Eric J., Anstrom, Kevin J., Clare, Robert M., DeWald, Tracy A., Psotka, Mitchell A., Ambrosy, Andrew P., Stevens, Gerin R., Rommel, John J., Alexy, Tamas, Ketema, Fassil, Kim, Dong-Yun, Desvigne-Nickens, Patrice, Pitt, Bertram, Eisenstein, Eric L., and Mentz, Robert J.

Published
2023
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17. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial

Author

Voors, Adriaan A., Angermann, Christiane E., Teerlink, John R., Collins, Sean P., Kosiborod, Mikhail, Biegus, Jan, Ferreira, João Pedro, Nassif, Michael E., Psotka, Mitchell A., Tromp, Jasper, Borleffs, C. Jan Willem, Ma, Changsheng, Comin-Colet, Joseph, Fu, Michael, Janssens, Stefan P., Kiss, Robert G., Mentz, Robert J., Sakata, Yasushi, Schirmer, Henrik, Schou, Morten, Schulze, P. Christian, Spinarova, Lenka, Volterrani, Maurizio, Wranicz, Jerzy K., Zeymer, Uwe, Zieroth, Shelley, Brueckmann, Martina, Blatchford, Jonathan P., Salsali, Afshin, and Ponikowski, Piotr

Published
2022
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18. A Composite Score Summarizing Use and Dosing of Evidence-Based Medical Therapies in Heart Failure: A Nationwide Cohort Study

Author

Johansen, Niklas Dyrby, Vaduganathan, Muthiah, Zahir, Deewa, Fiuzat, Mona, DeFilippis, Ersilia M., Januzzi, James L., Butler, Javed, O’Connor, Christopher M., Abraham, William T., Psotka, Mitchell A., McMurray, John J.V., Dewan, Pooja, Claggett, Brian L., Solomon, Scott D., Modin, Daniel, Butt, Jawad H., Jensen, Jens Ulrik Stæhr, Schou, Morten, Torp-Pedersen, Christian, Køber, Lars, Gislason, Gunnar H., and Biering-Sørensen, Tor

Published
2023
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20. Contemporary approach to cardiogenic shock care: a state-of-the-art review

Author

Mehta, Aditya, primary, Vavilin, Ilan, additional, Nguyen, Andrew H., additional, Batchelor, Wayne B., additional, Blumer, Vanessa, additional, Cilia, Lindsey, additional, Dewanjee, Aditya, additional, Desai, Mehul, additional, Desai, Shashank S., additional, Flanagan, Michael C., additional, Isseh, Iyad N., additional, Kennedy, Jamie L. W., additional, Klein, Katherine M., additional, Moukhachen, Hala, additional, Psotka, Mitchell A., additional, Raja, Anika, additional, Rosner, Carolyn M., additional, Shah, Palak, additional, Tang, Daniel G., additional, Truesdell, Alexander G., additional, Tehrani, Behnam N., additional, and Sinha, Shashank S., additional

Published
2024
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23. Abstract 11588: Multicenter Development and Validation of a Machine Learning Model to Predict Myocardial Recovery During LVAD Support: The UCAR Score

Author

Kyriakopoulos, Christos P, Taleb, Iosif, Wever-Pinzon, Omar, Selzman, Craig H, Kfoury, Abdallah, Bonios, Michael J, Wever-Pinzon, James, Yin, Michael Y, Tseliou, Eleni, Stehlik, Josef, Alharethi, Rami, Caine, William, Fang, James C, Koliopoulou, Antigone G, Sideris, Konstantinos, Nelson, Marisca, Elmer, Ashley, Dranow, Elizabeth, Singh, Ramesh, Psotka, Mitchell, Birks, Emma J, Slaughter, Mark S, Koenig, Steven, Kyvernitakis, Andreas, Hoffman, Karlee, Guglin, Maya, Kotter, John, Campbell, Kenneth S, Silvestry, Scott C, Vidic, Andrija, Raval, Nirav, Cowger, Jennifer, Kanwar, Manreet, Shah, Palak, and Drakos, Stavros G

Published
2022
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24. Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial

Author

Adams, Kirkwood, Long, Tammy, Bhatt, Kunal, Walker, Brandon, DeWald, Tracy, Biever, Kim, Axsom, Kelly, Acosta, Ariana, Murthy, Sandhya, Camilo, Angeline, Rich, Jonathan D., Martinez, Leslie, Testani, Jeffrey M., Tainsh, Jennifer, Smith, Bryan, Bennett, Amy, Vader, Justin, Stilinovic, Stephanie, McCulloch, Michael, Musso, Iris, Skopicki, Hal, Caikauskaite, Indre, Psotka, Mitchell A., Freiler, Allen, Heroux, Alain, Kartje, Carol, Lala-Trindade, Anuradha, Julien, Lovelyne, Stevens, Gerin, Leppla, Keriann, Tang, Wilson, Fonk, Teresa, Lev, Yair, Fizgerald, Kathleen, William, Preethi, Stroster, John, Eberly, Arthur, III, Workman, Celeste, Gottlieb, Stephen, Bowers-Lash, Mary, Haught, Walter Herbert, Abath, Cynthia, Grafton, Gillian, Neaton, Kelsey, Larned, Joshua, Ortiz, Mara-Li, Tejwani, Lokesh, Villalta, Tara, Mody, Freny, Strugatsky, Svetlana, Krim, Selim, Washington, Katasha, Robinson, Monique, Norton, Nadine, Smart, Frank, Worsham, Emily, Fang, James, Goldstein, Joe, Dunlap, Stephanie, Starnes, Nancy, Adler, Alexander, Theodorof, Virginia, Bell, Adrian, Kondramashin, Aleksey, Banerjee, Dipanjan, Yee, Michael, Ruiz-Duque, Ernesto, Larew, Cynthia, Mizyed, Ahmad, Sawaya, Kara, Friedman, Dennis, Rele, Shilpa, Rommel, John, Burkhart, Janet, Arhinful, Justice, Atkinson, Sam, Goyal, Parag, Samdani, Nidha, Hall, Michael, Watson, Connie, Hummel, Scott, Wells, Joanna, Shetty, Sanjay, White, Jackie, Haas, Donald, Marchand, Colleen, Vilaro, Juan, Osman, Alfaroug, Alexy, Tamas, Dicken, Julie, Guglin, Maya, Willig, Meghan, Ferguson, Andrew, Peabody, Mark, Herre, John, McMichael, Brittany, Clark, John, Britton, Nancy, Ambrosy, Andrew P., Tan, Thida, Heitner, John, Meykler, Marcella, Meadows, Judith, Halliday, Janet, Greene, Stephen J., Velazquez, Eric J., Anstrom, Kevin J., Eisenstein, Eric L., Sapp, Shelly, Morgan, Shelby, Harding, Tina, Sachdev, Vandana, Ketema, Fassil, Kim, Dong-Yun, Desvigne-Nickens, Patrice, Pitt, Bertram, and Mentz, Robert J.

Published
2021
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28. Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium

Author

Abraham, William T., Psotka, Mitchell A., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Mehran, Roxana, Ambardekar, Amrut V., Carson, Peter E., Jacob, Richard, Januzzi, James L., Jr., Konstam, Marvin A., Krucoff, Mitchell W., Lewis, Eldrin F., Piccini, Jonathan P., Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Zeitler, Emily P., Anker, Stefan D., and O’Connor, Christopher M.

Published
2020
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32. Constructing the Framework for Disease Modification in Pulmonary Arterial Hypertension.

Author

Zamanian, Roham T., Weatherald, Jason, Sweatt, Andrew J., Hemnes, Anna, Rashid, Moira, Psotka, Mitchell A., Bogaard, Harm J., and de Jesus Perez, Vinicio

Subjects
PULMONARY arterial hypertension, LUNG diseases, CRITICAL care medicine, ALZHEIMER'S disease, PULMONARY hypertension
Abstract

The article discusses the concept of disease modification in pulmonary arterial hypertension (PAH) and proposes a framework for its definition and evaluation in clinical trials. It defines disease modification as therapy-induced changes in clinical manifestations, disease trajectory, and outcomes due to an effect on the underlying pathophysiology. It proposes a randomized-withdrawal trial design to evaluate disease-modifying therapies effectively.

Published
2024
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36. Treatment Effects Of Empagliflozin In Hospitalized Heart Failure Patients Across The Range Of Left Ventricular Ejection Fraction - Results From The EMPULSE Trial

Author

Tromp, Jasper, primary, Kosiborod, Mikhail, additional, Angermann, Christiane, additional, Collins, Sean, additional, Teerlink, John, additional, Ponikowski, Piotr, additional, Biegus, Jan, additional, Ferreira, Joao Pedro, additional, Nassif, Michael, additional, Psotka, Mitchell, additional, Brückmann, Martina, additional, Blatchford, Jonathan, additional, Steubl, Dominik, additional, and Voors, Adriaan, additional

Published
2024
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37. Variation Of Prespecified Subgroups In Large-Scale HF Outcome Trials

Author

Dimond, Matthew, primary, Fabbri, Matteo, additional, Fiuzat, Mona, additional, Teerlink, John, additional, Abraham, William, additional, Mcmurray, John, additional, Psotka, Mitchell, additional, Konstam, Marvin, additional, Blumer, Vanessa, additional, Solomon, Scott, additional, Bristow, Michael, additional, Bozkurt, Biykem, additional, Butler, Javed, additional, Costanzo, Maria Rosa, additional, Felker, Michael, additional, Filippatos, Gerasimos, additional, Januzzi, James, additional, Metra, Marco, additional, Lindenfeld, JoAnn, additional, Mentz, Robert, additional, Saville, Ben, additional, Jessup, Mariell, additional, and O'Connor, Christopher, additional

Published
2024
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38. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies

Author

Lala, Anuradha, primary, Hamo, Carine E., additional, Bozkurt, Biykem, additional, Fiuzat, Mona, additional, Blumer, Vanessa, additional, Bukhoff, Daniel, additional, Butler, Javed, additional, Costanzo, Maria Rosa, additional, Felker, G. Michael, additional, Filippatos, Gerasimos, additional, Konstam, Marvin A., additional, McMurray, John J.V., additional, Mentz, Robert J., additional, Metra, Marco, additional, Psotka, Mitchell A., additional, Solomon, Scott D., additional, Teerlink, John, additional, Abraham, William T., additional, and O’Connor, Christopher M., additional

Published
2023
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39. Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development

Author

Psotka, Mitchell A., Fiuzat, Mona, Carson, Peter E., Kao, David P., Cerkvenik, Jeffrey, Schaber, Daniel E., Verta, Patrick, Kazmierski, Robert T., Shinnar, Meir, Stockbridge, Norman, Unger, Ellis F., Zuckerman, Bram, Butler, Javed, Felker, G. Michael, Konstam, Marvin A., Lindenfeld, JoAnn, Solomon, Scott D., Teerlink, John R., O'Connor, Christopher M., and Abraham, William T.

Published
2019
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42. Standardized Team-Based Care for Cardiogenic Shock

Author

Tehrani, Behnam N., Truesdell, Alexander G., Sherwood, Matthew W., Desai, Shashank, Tran, Henry A., Epps, Kelly C., Singh, Ramesh, Psotka, Mitchell, Shah, Palak, Cooper, Lauren B., Rosner, Carolyn, Raja, Anika, Barnett, Scott D., Saulino, Patricia, deFilippi, Christopher R., Gurbel, Paul A., Murphy, Charles E., and O’Connor, Christopher M.

Published
2019
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43. Treatment effects of empagliflozin in hospitalized heart failure patients across the range of left ventricular ejection fraction – Results from the EMPULSE trial.

Author

Tromp, Jasper, Kosiborod, Mikhail N., Angermann, Christiane E., Collins, Sean P., Teerlink, John R., Ponikowski, Piotr, Biegus, Jan, Ferreira, João Pedro, Nassif, Michael E., Psotka, Mitchell A., Brueckmann, Martina, Blatchford, Jonathan P, Steubl, Dominik, and Voors, Adriaan A.

Subjects
HEART failure, HEART failure patients, VENTRICULAR ejection fraction, SODIUM-glucose cotransporter 2 inhibitors, EMPAGLIFLOZIN, TREATMENT effectiveness
Abstract

Aim: The EMPULSE (EMPagliflozin in patients hospitalised with acUte heart faiLure who have been StabilizEd) trial showed that, compared to placebo, the sodium–glucose cotransporter 2 inhibitor empagliflozin (10 mg/day) improved clinical outcomes of patients hospitalized for acute heart failure (HF). We investigated whether efficacy and safety of empagliflozin were consistent across the spectrum of left ventricular ejection fraction (LVEF). Methods and results: A total of 530 patients hospitalized for acute de novo or decompensated HF were included irrespective of LVEF. For the present analysis, patients were classified as HF with reduced (HFrEF, LVEF ≤40%), mildly reduced (HFmrEF, LVEF 41–49%) or preserved (HFpEF, LVEF ≥50%) ejection fraction at baseline. The primary endpoint was a hierarchical outcome of death, worsening HF events (HFE) and quality of life over 90 days, assessed by the win ratio. Secondary endpoints included individual components of the primary endpoint and safety. Out of 523 patients with baseline data, 354 (67.7%) had HFrEF, 54 (10.3%) had HFmrEF and 115 (22.0%) had HFpEF. The clinical benefit (hierarchical composite of all‐cause death, HFE and Kansas City Cardiomyopathy Questionnaire total symptom score) of empagliflozin at 90 days compared to placebo was consistent across LVEF categories (≤40%: win ratio 1.35 [95% confidence interval 1.04, 1.75]; 41–49%: win ratio 1.25 [0.66, 2.37)] and ≥50%: win ratio 1.40 [0.87, 2.23], pinteraction = 0.96) with a favourable safety profile. Results were consistent across individual components of the hierarchical primary endpoint. Conclusion: The clinical benefit of empagliflozin proved consistent across LVEF categories in the EMPULSE trial. These results support early in‐hospital initiation of empagliflozin regardless of LVEF. [ABSTRACT FROM AUTHOR]

Published
2024
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45. BILIRUBIN ELEVATION AND OUTCOMES IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT

Author

STOTZ, ZACHARY, primary, MORAN, PATRICK, additional, CHANDEL, ABHIMANYU, additional, MAJETI, GIRISH, additional, SINGH, RAMESH, additional, LANTRY, JAMES H, additional, BUCHNER, JESSICA, additional, SIMOU, JIKERKHOUN, additional, CHOWDHURY, JUNAD, additional, GIBSON, JESSICA M, additional, ROSNER, CAROLYN, additional, BRAMMER, ROBERT C, additional, QUINN, CHRISTOPHER, additional, TANG, DANIEL, additional, DESAI, MEHUL, additional, STONE, PATRICK, additional, NGUYEN, VERONICA, additional, PSOTKA, MITCHELL, additional, and KING, CHRISTOPHER, additional

Published
2023
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46. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE

Author

Ferreira, João Pedro, primary, Blatchford, Jonathan P., additional, Teerlink, John R., additional, Kosiborod, Mikhail N., additional, Angermann, Christiane E., additional, Biegus, Jan, additional, Collins, Sean P., additional, Tromp, Jasper, additional, Nassif, Michael E., additional, Psotka, Mitchell A., additional, Comin‐Colet, Josep, additional, Mentz, Robert J., additional, Brueckmann, Martina, additional, Nordaby, Matias, additional, Ponikowski, Piotr, additional, and Voors, Adriaan A., additional

Published
2023
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47. Direct Myosin Activation by Omecamtiv Mecarbil for Heart Failure with Reduced Ejection Fraction

Author

Psotka, Mitchell A., Teerlink, John R., Barrett, James E., Editor-in-chief, Flockerzi, Veit, Series editor, Frohman, Michael A., Series editor, Geppetti, Pierangelo, Series editor, Hofmann, Franz B., Series editor, Michel, Martin C., Series editor, Page, Clive P, Series editor, Rosenthal, Walter, Series editor, Wang, KeWei, Series editor, Bauersachs, Johann, editor, Butler, Javed, editor, and Sandner, Peter, editor

Published
2017
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48. Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory

Author

O’Connor, Christopher M., Psotka, Mitchell A., Fiuzat, Mona, Lindenfeld, JoAnn, Abraham, William T., Bristow, Michael R., Canos, Daniel, Harrington, Robert A., Hillebrenner, Matt, Jessup, Mariell, Malik, Fady I., Solomon, Scott D., Stockbridge, Norman, Tcheng, James E., Unger, Ellis F., Whellan, David J., Zuckerman, Bram, and Califf, Robert M.

Published
2018
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