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1,777 results on '"Abraham, William T."'

4. Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial

Author

Bohra, Chandrashekar, Asch, Federico M., Lerakis, Stamatios, Little, Stephen H., Redfors, Björn, Zhou, Zhipeng, Li, Yanru, Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Abraham, William T., Lindenfeld, JoAnn, Mack, Michael J., Bax, Jeroen J., and Stone, Gregg W.

Published
2024
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10. Changes in Left Ventricular Function and Outcomes After Trancatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

Author

Lerakis, Stamatios, Kini, Annapoorna S., Giustino, Gennaro, Anastasius, Malcolm, Asch, Federico M., Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Mishell, Jacob M., Whisenant, Brian K., Rinaldi, Michael J., Kapadia, Samir R., Rajagopal, Vivek, Sarembock, Ian J., Brieke, Andreas, Tang, Gilbert H.L., Li, Yanru, Alu, Maria C., Lindenfeld, JoAnn, Abraham, William T., Sharma, Samin K., Mack, Michael J., and Stone, Gregg W.

Published
2024
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12. 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

13. Cross-Validation of Risk Scores for Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation

Author

Estévez-Loureiro, Rodrigo, Shah, Neeraj, Raposeiras-Roubin, Sergio, Kotinkaduwa, Lak N., Madhavan, Mahesh V., Gray, William A., Lindenfeld, JoAnn, Adamo, Marianna, Abraham, William T., Freixa, Xavier, Grayburn, Paul A., Arzamendi, Dabit, Kar, Saibal, Benito-González, Tomas, Lim, D. Scott, Montefusco, Antonio, Redfors, Björn, Pascual, Isaac, Nombela-Franco, Luis, Rodés-Cabau, Josep, Shuvy, Mony, Moñivas, Vanessa, Godino, Cosmo, Mack, Michael J., Bedogni, Francesco, and Stone, Gregg W.

Published
2024
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14. 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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20. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

Author

Anker, Stefan D, Butler, Javed, Khan, Muhammad Shahzeb, Abraham, William T, Bauersachs, Johann, Bocchi, Edimar, Bozkurt, Biykem, Braunwald, Eugene, Chopra, Vijay K, Cleland, John G, Ezekowitz, Justin, Filippatos, Gerasimos, Friede, Tim, Hernandez, Adrian F, Lam, Carolyn SP, Lindenfeld, JoAnn, McMurray, John JV, Mehra, Mandeep, Metra, Marco, Packer, Milton, Pieske, Burkert, Pocock, Stuart J, Ponikowski, Piotr, Rosano, Giuseppe MC, Teerlink, John R, Tsutsui, Hiroyuki, Van Veldhuisen, Dirk J, Verma, Subodh, Voors, Adriaan A, Wittes, Janet, Zannad, Faiez, Zhang, Jian, Seferovic, Petar, and Coats, Andrew JS

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease, Prevention, Good Health and Well Being, Betacoronavirus, COVID-19, Clinical Trials as Topic, Coronavirus Infections, Europe, Heart Failure, Humans, Informed Consent, Pandemics, Patient Selection, Pneumonia, Viral, Research Design, SARS-CoV-2, Heart failure, Clinical trials, Coronavirus, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

Published
2020

24. 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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25. 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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29. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score–Matched Comparison

Author

Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Lim, D. Scott, Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean-François, von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, JoAnn, Modine, Thomas, Stone, Gregg W., and Granada, Juan F.

Published
2023
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30. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

Author

Perl, Leor, Meerkin, David, D'amario, Domenico, Avraham, Binyamin Ben, Gal, Tuvia Ben, Weitsman, Tatyana, Hasin, Tal, Ince, Hüseyin, Feickert, Sebastian, D'ancona, Giuseppe, Schaefer, Ulrich, Sievert, Horst, Leyva, Francisco, Whinnett, Zachary I., Di Mario, Carlo, Jonas, Michael, Glikson, Michael, Habib, Manhal, Caspi, Oren, Koren, Oran, Abraham, William T., Kornowski, Ran, and Crea, Filippo

Published
2022
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32. 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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34. Artificial Intelligence in Cardiovascular Clinical Trials.

Author

Cunningham, Jonathan W., Abraham, William T., Bhatt, Ankeet S., Dunn, Jessilyn, Felker, G. Michael, Jain, Sneha S., Lindsell, Christopher J., Mace, Matthew, Martyn, Trejeeve, Shah, Rashmee U., Tison, Geoffrey H., Fakhouri, Tala, Psotka, Mitchell A., Krumholz, Harlan, Fiuzat, Mona, O'Connor, Christopher M., and Solomon, Scott D.

Abstract

Randomized clinical trials are the gold standard for establishing the efficacy and safety of cardiovascular therapies. However, current pivotal trials are expensive, lengthy, and insufficiently diverse. Emerging artificial intelligence (AI) technologies can potentially automate and streamline clinical trial operations. This review describes opportunities to integrate AI throughout a trial's life cycle, including designing the trial, identifying eligible patients, obtaining informed consent, ascertaining physiological and clinical event outcomes, interpreting imaging, and analyzing or disseminating the results. Nevertheless, AI poses risks, including generating inaccurate results, amplifying biases against underrepresented groups, and violating patient privacy. Medical journals and regulators are developing new frameworks to evaluate AI research tools and the data they generate. Given the high-stakes role of randomized trials in medical decision making, AI must be integrated carefully and transparently to protect the validity of trial results. [ABSTRACT FROM AUTHOR]

Published
2024
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35. In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure.

Author

Pfeiffer, Michael, Boehmer, John, Gorcsan, John, Eguchi, Shunsuke, Orihara, Yoshiyuki, Perl, Michal Laufer, Eigler, Neal, Abraham, William T., Villota, Julio Nuñez, Lee, Elizabeth, Bayés‐Genís, Antoni, Moravsky, Gil, Kar, Saibal, Zile, Michael R., Holcomb, Richard, Anker, Stefan D., Stone, Gregg W., Rodés‐Cabau, Josep, Lindenfeld, JoAnn, and Bax, Jeroen J.

Subjects
COMPUTATIONAL fluid dynamics, FLUID dynamics, PROPERTIES of fluids, DISCHARGE coefficient, HEART failure patients, TRANSESOPHAGEAL echocardiography
Abstract

Aims: Interatrial shunts are under evaluation as a treatment for heart failure (HF); however, their in vivo flow performance has not been quantitatively studied. We aimed to investigate the fluid dynamics properties of the 0.51 cm orifice diameter Ventura shunt and assess its lumen integrity with serial transesophageal echocardiography (TEE). Methods and results: Computational fluid dynamics (CFD) and bench flow tests were used to establish the flow‐pressure relationship of the shunt. Open‐label patients from the RELIEVE‐HF trial underwent TEE at shunt implant and at 6 and 12 month follow‐up. Shunt effective diameter (Deff) was derived from the vena contracta, and flow was determined by the continuity equation. CFD and bench studies independently validated that the shunt's discharge coefficient was 0.88 to 0.89. The device was successfully implanted in all 97 enrolled patients; mean age was 70 ± 11 years, 97% were NYHA class III, and 51% had LVEF ≤40%. Patency was confirmed in all instances, except for one stenotic shunt at 6 months. Deff remained unchanged from baseline at 12 months (0.47 ± 0.01 cm, P = 0.376), as did the trans‐shunt mean pressure gradient (5.1 ± 3.9 mmHg, P = 0.316) and flow (1137 ± 463 mL/min, P = 0.384). TEE measured flow versus pressure closely correlated (R2 ≥ 0.98) with a fluid dynamics model. At 12 months, the pulmonary/systemic flow Qp/Qs ratio was 1.22 ± 0.12. Conclusions: When implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Dose-limiting, adverse event–associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial

Author

Abraham, William T., Piccini, Jonathan P., Dufton, Christopher, Carroll, Ian A., Healey, Jeffrey S., O’Connor, Christopher M., Marshall, Debra, Aleong, Ryan, van Veldhuisen, Dirk J., Rienstra, Michiel, Wilton, Stephen B., White, Michel, Sauer, William H., Anand, Inder S., Huebler, Sophia P., Connolly, Stuart J., and Bristow, Michael R.

Published
2022
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38. Risk Factor Burden, Heart Failure, and Survival in Women of Different Ethnic Groups: Insights From the Women's Health Initiative.

Author

Breathett, Khadijah, Leng, Iris, Foraker, Randi E, Abraham, William T, Coker, Laura, Whitfield, Keith E, Shumaker, Sally, Manson, JoAnn E, Eaton, Charles B, Howard, Barbara V, Ijioma, Nkechinyere, Cené, Crystal W, Martin, Lisa W, Johnson, Karen C, and Klein, Liviu

Subjects
Humans, Proportional Hazards Models, Risk Factors, Survival Analysis, Aged, Middle Aged, African Americans, Women's Health, Female, Heart Failure, Ethnicity, Racial Groups, ethnic groups, heart failure, risk factors, survival, women, Cardiovascular, Heart Disease, Prevention, Clinical Research, Cardiovascular System & Hematology, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Medical Physiology
Abstract

BackgroundThe higher risk of heart failure (HF) in African-American and Hispanic women compared with white women is related to the higher burden of risk factors (RFs) in minorities. However, it is unclear if there are differences in the association between the number of RFs for HF and the risk of development of HF and death within racial/ethnic groups.Methods and resultsIn the WHI (Women's Health Initiative; 1993-2010), African-American (n=11 996), white (n=18 479), and Hispanic (n=5096) women with 1, 2, or 3+ baseline RFs were compared with women with 0 RF within their respective racial/ethnic groups to assess risk of developing HF or all-cause mortality before and after HF, using survival analyses. After adjusting for age, socioeconomic status, and hormone therapy, the subdistribution hazard ratio (95% confidence interval) of developing HF increased as number of RFs increased (P

Published
2018

48. Extracorporeal Ultrafiltration for Fluid Overload in Heart Failure Current Status and Prospects for Further Research

Author

Costanzo, Maria Rosa, Ronco, Claudio, Abraham, William T, Agostoni, Piergiuseppe, Barasch, Jonathan, Fonarow, Gregg C, Gottlieb, Stephen S, Jaski, Brian E, Kazory, Amir, Levin, Allison P, Levin, Howard R, Marenzi, Giancarlo, Mullens, Wilfried, Negoianu, Dan, Redfield, Margaret M, Tang, WH Wilson, Testani, Jeffrey M, and Voors, Adriaan A

Subjects
Kidney Disease, Heart Disease, Cardiovascular, Renal and urogenital, Blood Volume, Diuretics, Heart Failure, Hemofiltration, Humans, Pilot Projects, Randomized Controlled Trials as Topic, biomarkers, creatinine, diuretics, glomerular filtration rate, venous congestion, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients' vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration.

Published
2017

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