Search

Your search keyword '"Leifer, Eric S"' showing total 256 results
Start Over Author "Leifer, Eric S"
256 results on '"Leifer, Eric S"'

1. Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial

Author

Avancini Caramori, PR, Esteves Hernandes, M, Babudieri, S, Contoli, M, Fernando, M, Gonzalez Juanatey, JR, Ibañez Estellez, F, Mateos, E, Tidswell, M, Akala, O, Pursley, M, Jathavedam, A, Markley, J, Gelman, M, Ajani, Z, Mackay, F, Kunisaki, K, Martin, K, Exline, M, Huggins, J, Nicholson, L, Lim, G, Aboudara, M, Sherwin, R, Torbati, S, Wilson, J, Latorre, JG, Busch, J, Albertson, T, Matthay, M, Gandotra, S, Joseph, B, Hudock, K, Iovine, N, Quigley, J, Hyzy, R, Kutcher, M, Huang, D, Pandey, A, Sheehan, J, Solankhi, N, Rodriguez, W, Shah, B, Khanna, A, Bochicchio, G, McCarthy, M, Pan, S, Balasubraman, P, Kosiborod, Mikhail N, Windsor, Sheryl L, Vardeny, Orly, Berger, Jeffrey S, Reynolds, Harmony R, Boumakis, Stavroula, Althouse, Andrew D, Solomon, Scott D, Bhatt, Ankeet S, Peikert, Alexander, Luther, James F, Leifer, Eric S, Kindzelski, Andrei L, Cushman, Mary, Ng Gong, Michelle, Kornblith, Lucy Z, Khatri, Pooja, Kim, Keri S, Baumann Kreuziger, Lisa, Javaheri, Ali, Carpio, Carlos, Wahid, Lana, Lopez-Sendon Moreno, Jose, Alonso, Alvaro, Ho, Minh Quang, Lopez-Sendon, Jose, Lopes, Renato D, Curtis, Jeffrey L, Kirwan, Bridget-Anne, Geraci, Mark W, Neal, Matthew D, and Hochman, Judith S

Published
2024
Full Text
View/download PDF

3. Blood and Marrow Transplant Clinical Trials Network State of the Science Symposium 2021: Looking Forward as the Network Celebrates its 20th Year

Author

Heslop, Helen E, Stadtmauer, Edward A, Levine, John E, Ballen, Karen K, Chen, Yi-Bin, DeZern, Amy E, Eapen, Mary, Hamadani, Mehdi, Hamilton, Betty K, Hari, Parameswaran, Jones, Richard J, Logan, Brent R, Kean, Leslie S, Leifer, Eric S, Locke, Frederick L, Maziarz, Richard T, Nemecek, Eneida R, Pasquini, Marcelo, Phelan, Rachel, Riches, Marcie L, Shaw, Bronwen E, Walters, Mark C, Foley, Amy, Devine, Steven M, and Horowitz, Mary M

Subjects
Stem Cell Research, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Bone Marrow Transplantation, Clinical Trials as Topic, Hematopoietic Stem Cell Transplantation, Humans, Transplants, BMT, Cell Therapy, Clinical Trial
Abstract

In 2021 the BMT CTN held the 4th State of the Science Symposium where the deliberations of 11 committees concerning major topics pertinent to a particular disease, modality, or complication of transplant, as well as two committees to consider clinical trial design and inclusion, diversity, and access as cross-cutting themes were reviewed. This article summarizes the individual committee reports and their recommendations on the highest priority questions in hematopoietic stem cell transplant and cell therapy to address in multicenter trials.

Published
2021

4. Effect of therapeutic-dose heparin on severe acute kidney injury and death in noncritically ill patients hospitalized for COVID-19: a prespecified secondary analysis of the ACTIV4a and ATTACC randomized trial

Author

Smilowitz, Nathaniel R., Hade, Erinn M., Kornblith, Lucy Z., Castellucci, Lana A., Cushman, Mary, Farkouh, Michael, Gong, Michelle N., Heath, Anna, Hunt, Beverly J., Kim, Keri S., Kindzelski, Andrei, Lawler, Patrick, Leaf, David E., Goligher, Ewan, Leifer, Eric S., McVerry, Bryan J., Reynolds, Harmony R., Zarychanski, Ryan, Hochman, Judith S., Neal, Matthew D., and Berger, Jeffrey S.

Published
2023
Full Text
View/download PDF

5. 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
Full Text
View/download PDF

6. Effect of the P-Selectin Inhibitor Crizanlizumab on Survival Free of Organ Support in Patients Hospitalized for COVID-19: A Randomized Controlled Trial

Author

Solomon, Scott D., Lowenstein, Charles J., Bhatt, Ankeet S., Peikert, Alexander, Vardeny, Orly, Kosiborod, Mikhail N., Berger, Jeffrey S., Reynolds, Harmony R., Mavromichalis, Stephanie, Barytol, Anya, Althouse, Andrew D., Luther, James F., Leifer, Eric S., Kindzelski, Andrei L., Cushman, Mary, Gong, Michelle N., Kornblith, Lucy Z., Khatri, Pooja, Kim, Keri S., Baumann Kreuziger, Lisa, Wahid, Lana, Kirwan, Bridget-Anne, Geraci, Mark W., Neal, Matthew D., and Hochman, Judith S.

Published
2023
Full Text
View/download PDF

7. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial

Author

CHOUAIRI, FOUAD, FUERY, MICHAEL A., MULLAN, CLANCY W., CARABALLO, CESAR, SEN, SOUNOK, MAULION, CHRISTOPHER, WILKINSON, SAMUEL T., SURTI, TORAL, MCCULLOUGH, MEGAN, MILLER, P. ELLIOTT, PACOR, JUSTIN, LEIFER, ERIC S., FELKER, G. MICHAEL, VELAZQUEZ, ERIC J., FIUZAT, MONA, O'CONNOR, CHRISTOPHER M., JANUZZI, JAMES L, DESAI, NIHAR R., and AHMAD, TARIQ

Published
2021
Full Text
View/download PDF

9. Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial

Author

Kosiborod, Mikhail N, Windsor, Sheryl L, Vardeny, Orly, Berger, Jeffrey S, Reynolds, Harmony R, Boumakis, Stavroula, Althouse, Andrew D, Solomon, Scott D, Bhatt, Ankeet S, Peikert, Alexander, Luther, James F, Leifer, Eric S, Kindzelski, Andrei L, Cushman, Mary, Ng Gong, Michelle, Kornblith, Lucy Z, Khatri, Pooja, Kim, Keri S, Baumann Kreuziger, Lisa, Javaheri, Ali, Carpio, Carlos, Wahid, Lana, Lopez-Sendon Moreno, Jose, Alonso, Alvaro, Ho, Minh Quang, Lopez-Sendon, Jose, Lopes, Renato D, Curtis, Jeffrey L, Kirwan, Bridget-Anne, Geraci, Mark W, Neal, Matthew D, Hochman, Judith S, Avancini Caramori, PR, Esteves Hernandes, M, Babudieri, S, Contoli, M, Fernando, M, Gonzalez Juanatey, JR, Ibañez Estellez, F, Mateos, E, Tidswell, M, Akala, O, Pursley, M, Jathavedam, A, Markley, J, Gelman, M, Ajani, Z, Mackay, F, Kunisaki, K, Martin, K, Exline, M, Huggins, J, Nicholson, L, Lim, G, Aboudara, M, Sherwin, R, Torbati, S, Wilson, J, Latorre, JG, Busch, J, Albertson, T, Matthay, M, Gandotra, S, Joseph, B, Hudock, K, Iovine, N, Quigley, J, Hyzy, R, Kutcher, M, Huang, D, Pandey, A, Sheehan, J, Solankhi, N, Huang, D, Rodriguez, W, Shah, B, Khanna, A, Bochicchio, G, McCarthy, M, Pan, S, and Balasubraman, P

Abstract

Patients hospitalised for COVID-19 are at risk for multiorgan failure and death. Sodium–glucose co-transporter-2 (SGLT2) inhibitors provide cardiovascular and kidney protection in patients with cardiometabolic conditions and could provide organ protection during COVID-19. We aimed to investigate whether SGLT2 inhibitors can reduce the need for organ support in patients hospitalised for COVID-19.

Published
2024
Full Text
View/download PDF

10. Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial.

Author

Joo, Jungnam, Leifer, Eric S, Proschan, Michael A, Troendle, James F, Reynolds, Harmony R, Hade, Erinn A, Lawler, Patrick R, Kim, Dong-Yun, and Geller, Nancy L

Subjects
CLINICAL trials, FUTILE medical care, EXPERIMENTAL design, COMPARATIVE studies, COVID-19
Abstract

Background: The coronavirus disease 2019 pandemic highlighted the need to conduct efficient randomized clinical trials with interim monitoring guidelines for efficacy and futility. Several randomized coronavirus disease 2019 trials, including the Multiplatform Randomized Clinical Trial (mpRCT), used Bayesian guidelines with the belief that they would lead to quicker efficacy or futility decisions than traditional "frequentist" guidelines, such as spending functions and conditional power. We explore this belief using an intuitive interpretation of Bayesian methods as translating prior opinion about the treatment effect into imaginary prior data. These imaginary observations are then combined with actual observations from the trial to make conclusions. Using this approach, we show that the Bayesian efficacy boundary used in mpRCT is actually quite similar to the frequentist Pocock boundary. Methods: The mpRCT's efficacy monitoring guideline considered stopping if, given the observed data, there was greater than 99% probability that the treatment was effective (odds ratio greater than 1). The mpRCT's futility monitoring guideline considered stopping if, given the observed data, there was greater than 95% probability that the treatment was less than 20% effective (odds ratio less than 1.2). The mpRCT used a normal prior distribution that can be thought of as supplementing the actual patients' data with imaginary patients' data. We explore the effects of varying probability thresholds and the prior-to-actual patient ratio in the mpRCT and compare the resulting Bayesian efficacy monitoring guidelines to the well-known frequentist Pocock and O'Brien–Fleming efficacy guidelines. We also contrast Bayesian futility guidelines with a more traditional 20% conditional power futility guideline. Results: A Bayesian efficacy and futility monitoring boundary using a neutral, weakly informative prior distribution and a fixed probability threshold at all interim analyses is more aggressive than the commonly used O'Brien–Fleming efficacy boundary coupled with a 20% conditional power threshold for futility. The trade-off is that more aggressive boundaries tend to stop trials earlier, but incur a loss of power. Interestingly, the Bayesian efficacy boundary with 99% probability threshold is very similar to the classic Pocock efficacy boundary. Conclusions: In a pandemic where quickly weeding out ineffective treatments and identifying effective treatments is paramount, aggressive monitoring may be preferred to conservative approaches, such as the O'Brien–Fleming boundary. This can be accomplished with either Bayesian or frequentist methods. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

11. A comparison of computational algorithms for the Bayesian analysis of clinical trials.

Author

Chen, Ziming, Berger, Jeffrey S, Castellucci, Lana A, Farkouh, Michael, Goligher, Ewan C, Hade, Erinn M, Hunt, Beverley J, Kornblith, Lucy Z, Lawler, Patrick R, Leifer, Eric S, Lorenzi, Elizabeth, Neal, Matthew D, Zarychanski, Ryan, and Heath, Anna

Subjects
ANTICOAGULANTS, STATISTICAL models, RESEARCH funding, PROBABILITY theory, HEPARIN, CLINICAL trials, DESCRIPTIVE statistics, SYSTEM analysis, RESEARCH methodology, SURVIVAL analysis (Biometry), LENGTH of stay in hospitals, COMPARATIVE studies, ALGORITHMS, COVID-19
Abstract

Background: Clinical trials are increasingly using Bayesian methods for their design and analysis. Inference in Bayesian trials typically uses simulation-based approaches such as Markov Chain Monte Carlo methods. Markov Chain Monte Carlo has high computational cost and can be complex to implement. The Integrated Nested Laplace Approximations algorithm provides approximate Bayesian inference without the need for computationally complex simulations, making it more efficient than Markov Chain Monte Carlo. The practical properties of Integrated Nested Laplace Approximations compared to Markov Chain Monte Carlo have not been considered for clinical trials. Using data from a published clinical trial, we aim to investigate whether Integrated Nested Laplace Approximations is a feasible and accurate alternative to Markov Chain Monte Carlo and provide practical guidance for trialists interested in Bayesian trial design. Methods: Data from an international Bayesian multi-platform adaptive trial that compared therapeutic-dose anticoagulation with heparin to usual care in non-critically ill patients hospitalized for COVID-19 were used to fit Bayesian hierarchical generalized mixed models. Integrated Nested Laplace Approximations was compared to two Markov Chain Monte Carlo algorithms, implemented in the software JAGS and stan, using packages available in the statistical software R. Seven outcomes were analysed: organ-support free days (an ordinal outcome), five binary outcomes related to survival and length of hospital stay, and a time-to-event outcome. The posterior distributions for the treatment and sex effects and the variances for the hierarchical effects of age, site and time period were obtained. We summarized these posteriors by calculating the mean, standard deviations and the 95% equitailed credible intervals and presenting the results graphically. The computation time for each algorithm was recorded. Results: The average overlap of the 95% credible interval for the treatment and sex effects estimated using Integrated Nested Laplace Approximations was 96% and 97.6% compared with stan, respectively. The graphical posterior densities for these effects overlapped for all three algorithms. The posterior mean for the variance of the hierarchical effects of age, site and time estimated using Integrated Nested Laplace Approximations are within the 95% credible interval estimated using Markov Chain Monte Carlo but the average overlap of the credible interval is lower, 77%, 85.6% and 91.3%, respectively, for Integrated Nested Laplace Approximations compared to stan. Integrated Nested Laplace Approximations and stan were easily implemented in clear, well-established packages in R, while JAGS required the direct specification of the model. Integrated Nested Laplace Approximations was between 85 and 269 times faster than stan and 26 and 1852 times faster than JAGS. Conclusion: Integrated Nested Laplace Approximations could reduce the computational complexity of Bayesian analysis in clinical trials as it is easy to implement in R, substantially faster than Markov Chain Monte Carlo methods implemented in JAGS and stan, and provides near identical approximations to the posterior distributions for the treatment effect. Integrated Nested Laplace Approximations was less accurate when estimating the posterior distribution for the variance of hierarchical effects, particularly for the proportional odds model, and future work should determine if the Integrated Nested Laplace Approximations algorithm can be adjusted to improve this estimation. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

14. Variables Measured During Cardiopulmonary Exercise Testing as Predictors of Mortality in Chronic Systolic Heart Failure

Author

Keteyian, Steven J, Patel, Mahesh, Kraus, William E, Brawner, Clinton A, McConnell, Timothy R, Piña, Ileana L, Leifer, Eric S, Fleg, Jerome L, Blackburn, Gordon, Fonarow, Gregg C, Chase, Paul J, Piner, Lucy, Vest, Marianne, O’Connor, Christopher M, Ehrman, Jonathan K, Walsh, Mary N, Ewald, Gregory, Bensimhon, Dan, Russell, Stuart D, and Investigators, HF-ACTION

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Cardiovascular, Clinical Research, Clinical Trials and Supportive Activities, 6.7 Physical, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Aged, Cause of Death, Disease Progression, Exercise Test, Female, Follow-Up Studies, Heart Failure, Systolic, Humans, Male, Middle Aged, Oxygen Consumption, Predictive Value of Tests, Prognosis, Stroke Volume, Survival Rate, Time Factors, United States, peak VO2, respiratory exchange ratio, sex, survival, HF-ACTION Investigators, peak Vo(2), Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundData from a cardiopulmonary exercise (CPX) test are used to determine prognosis in patients with chronic heart failure (HF). However, few published studies have simultaneously compared the relative prognostic strength of multiple CPX variables.ObjectivesThe study sought to describe the strength of the association among variables measured during a CPX test and all-cause mortality in patients with HF with reduced ejection fraction (HFrEF), including the influence of sex and patient effort, as measured by respiratory exchange ratio (RER).MethodsAmong patients (n = 2,100, 29% women) enrolled in the HF-ACTION (HF-A Controlled Trial Investigating Outcomes of exercise traiNing) trial, 10 CPX test variables measured at baseline (e.g., peak oxygen uptake [Vo2], exercise duration, percent predicted peak Vo2 [%ppVo2], ventilatory efficiency) were examined.ResultsOver a median follow-up of 32 months, there were 357 deaths. All CPX variables, except RER, were related to all-cause mortality (all p < 0.0001). Both %ppVo2 and exercise duration were equally able to predict (Wald chi-square: ∼141) and discriminate (c-index: 0.69) mortality. Peak Vo2 (ml·kg(-1)·min(-1)) was the strongest predictor of mortality among men (Wald chi-square: 129) and exercise duration among women (Wald chi-square: 41). Multivariable analyses showed that %ppVo2, exercise duration, and peak Vo2 (ml·kg(-1)·min(-1)) were similarly able to predict and discriminate mortality. In men, a 10% 1-year mortality rate corresponded to a peak Vo2 of 10.9 ml·kg(-1)·min(-1) versus 5.3 ml·kg(-1)·min(-1) in women.ConclusionsPeak Vo2, exercise duration, and % ppVo2 carried the strongest ability to predict and discriminate the likelihood of death in patients with HFrEF. The prognosis associated with a given peak Vo2 differed by sex. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437).

Published
2016

16. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction

Author

Januzzi, James L., Jr., Ahmad, Tariq, Mulder, Hillary, Coles, Adrian, Anstrom, Kevin J., Adams, Kirkwood F., Ezekowitz, Justin A., Fiuzat, Mona, Houston-Miller, Nancy, Mark, Daniel B., Piña, Ileana L., Passmore, Gayle, Whellan, David J., Cooper, Lawton S., Leifer, Eric S., Desvigne-Nickens, Patrice, Felker, G. Michael, and O'Connor, Christopher M.

Published
2019
Full Text
View/download PDF

19. Umbilical Cord Blood or HLA-Haploidentical Transplantation: Real-World Outcomes versus Randomized Trial Outcomes

Author

O'Donnell, Paul V., Brunstein, Claudio G., Fuchs, Ephraim J., Zhang, Mei-Jie, Allbee-Johnson, Mariam, Antin, Joseph H., Leifer, Eric S., Elmariah, Hany, Grunwald, Michael R., Hashmi, Hamza, Horowitz, Mary M., Magenau, John M., Majhail, Navneet, Milano, Filippo, Morris, Lawrence E., Rezvani, Andrew R., McGuirk, Joseph P., Jones, Richard J., and Eapen, Mary

Published
2022
Full Text
View/download PDF

20. Supervised Exercise Training for Chronic Heart Failure With Preserved Ejection Fraction: A Scientific Statement From the American Heart Association and American College of Cardiology

Author

Sachdev, Vandana, primary, Sharma, Kavita, additional, Keteyian, Steven J., additional, Alcain, Charina F., additional, Desvigne-Nickens, Patrice, additional, Fleg, Jerome L., additional, Florea, Viorel G., additional, Franklin, Barry A., additional, Guglin, Maya, additional, Halle, Martin, additional, Leifer, Eric S., additional, Panjrath, Gurusher, additional, Tinsley, Emily A., additional, Wong, Renee P., additional, and Kitzman, Dalane W., additional

Published
2023
Full Text
View/download PDF

24. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Berry, Scott M, McArthur, Colin J, Neal, Matthew D, Hochman, Judith S, Webb, Steven A, Zarychanski, Ryan, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Kreuziger, Lisa Baumann, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Dzavik, Vladimir, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Kornblith, Aaron E, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, Le Gal, Gregoire, Leeper, Christine M, Leifer, Eric S, Lim, George, Lima, Felipe Gallego, Linstrum, Kelsey, Litton, Edward, Lopez-Sendon, Jose, Lother, Sylvain A, Marten, Nicole, Marinez, Andrea Saud, Martinez, Mary, Garcia, Eduardo Mateos, Mavromichalis, Stavroula, McAuley, Daniel F, McDonald, Emily G, McGlothlin, Anna, McGuinness, Shay P, Middeldorp, Saskia, Montgomery, Stephanie K, Mouncey, Paul R, Murthy, Srinivas, Nair, Girish B, Nair, Rahul, Nichol, Alistair D, Nicolau, Jose C, Nunez-Garcia, Brenda, Park, John J, Park, Pauline K, Parke, Rachael L, Parker, Jane C, Parnia, Sam, Paul, Jonathan D, Pompilio, Mauricio, Quigley, John G, Rosenson, Robert S, Rost, Natalia S, Rowan, Kathryn, Santos, Fernanda O, Santos, Marlene, Santos, Mayler O, Satterwhite, Lewis, Saunders, Christina T, Schreiber, Jake, Schutgens, Roger EG, Seymour, Christopher W, Siegal, Deborah M, Silva, Delcio G, Singhal, Aneesh B, Slutsky, Arthur S, Solvason, Dayna, Turner, Anne M, Van Bentum-Puijk, Wilma, van de Veerdonk, Frank L, van Diepen, Sean, Vazquez-Grande, Gloria, Wahid, Lana, Wareham, Vanessa, Widmer, R Jay, Wilson, Jennifer G, Yuriditsky, Eugene, Zhong, Yongqi, Investigators, REMAP-CAP, Investigators, ACTIV-4a, Investigators, ATTACC, NIHR, National Institute for Health Research, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), National Institutes of Health, NIH: 1OT2HL156812-01, AR7-162822, OTA-20-011, RP-2015-06-18, National Heart, Lung, and Blood Institute, NHLBI, Amgen, CancerCare Manitoba Foundation, CCMF, University of Manitoba, UM, Health Research Board, HRB: CTN 2014-012, Canadian Institutes of Health Research, CIHR: 158584, 447335, COVID-19, National Institute for Health Research, NIHR, European Commission, EC: 602525, FP7-HEALTH-2013-INNOVATION, National Health and Medical Research Council, NHMRC: APP1101719, APP1116530, Health Research Council of New Zealand, HRC: 16/631, Eisai, Ministère des Affaires Sociales et de la Santé: PHRC-20-0147, Université Pierre et Marie Curie, UPMC, Horizon 2020: 101003589, NIHR Imperial Biomedical Research Centre, BRC, Minderoo Foundation, REMAP-CAP was supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (grant 602525) and the Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (grant 101003589) and by grants from the Australian National Health and Medical Research Council (APP1101719 and APP1116530), the Health Research Council of New Zealand (16/631), the Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant 158584 and COVID-19 Rapid Research Operating Grant 447335), the U.K. National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Amgen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc, Thistledown Foundation, Research Manitoba, CancerCare Manitoba Foundation, Victoria General Hospital Foundation, Ontario Ministry of Health, and the Peter Munk Cardiac Centre. The ACTIV-4a platform was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and administered through OTA-20-011 and was supported in part by NIH agreement 1OT2HL156812-01. Dr. Goligher is the recipient of an Early Career Investigator award from the Canadian Institutes of Health Research (grant AR7-162822). Dr. Gordon is funded by an NIHR Research Professorship (RP-2015-06-18). Dr. Turgeon is funded by a Canada Research Chair-Tier 2. Dr. Zarychanski is the recipient of the Lyonel G. Israels Research Chair in Hematology (University of Manitoba)., Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Investigators, REMAP-CAP, Investigators, ACTIV-4a, Investigators, ATTACC, REMAP-CAP Investigators, ACTIV-4a Investigators, and ATTACC Investigators

Subjects
Male, covid-19, anticoagulation, adaptive platform trial, [SDV]Life Sciences [q-bio], Critical Illness, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Hemorrhage, 030204 cardiovascular system & hematology, heparin, COVID-19/drug therapy, 03 medical and health sciences, 0302 clinical medicine, Medicine, General & Internal, Hemorrhage/chemically induced, General & Internal Medicine, Odds Ratio, thrombosis, covid-19, Humans, 030212 general & internal medicine, Hospital Mortality, Treatment Failure, Heparin/administration & dosage, anticoagulation, 11 Medical and Health Sciences, Aged, Anticoagulants/administration & dosage, Science & Technology, Thrombosis/prevention & control, Heparin, low molecular weight heparin, Anticoagulants, COVID-19, Thrombosis, General Medicine, Middle Aged, Respiration, Artificial, 3. Good health, COVID-19 Drug Treatment, critical care, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Logistic Models, ACTIV-4a Investigators, Female, Human medicine, ATTACC Investigators, REMAP-CAP Investigators, Covid-19, Life Sciences & Biomedicine
Abstract

BACKGROUNDThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.METHODSIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.RESULTSThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support–free days was 1 (interquartile range, −1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, −1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio CONCLUSIONSIn critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707. opens in new tab, NCT04505774. opens in new tab, NCT04359277. opens in new tab, and NCT04372589. opens in new tab.)

Published
2021
Full Text
View/download PDF

25. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, Le Gal, Grégoire, Leeper, Christine M, Leifer, Eric S, Lim, George, Gallego Lima, Felipe, Linstrum, Kelsey, Litton, Edward, Lopez-Sendon, Jose, Lother, Sylvain A, Marten, Nicole, Saud Marinez, Andréa, Martinez, Mary, Mateos Garcia, Eduardo, Mavromichalis, Stavroula, McAuley, Daniel F, McDonald, Emily G, McGlothlin, Anna, McGuinness, Shay P, Middeldorp, Saskia, Montgomery, Stephanie K, Mouncey, Paul R, Murthy, Srinivas, Nair, Girish B, Nair, Rahul, Nichol, Alistair D, Nicolau, Jose C, Nunez-Garcia, Brenda, Park, John J, Park, Pauline K, Parke, Rachael L, Parker, Jane C, Parnia, Sam, Paul, Jonathan D, Pompilio, Mauricio, Quigley, John G, Rosenson, Robert S, Rost, Natalia S, Rowan, Kathryn, Santos, Fernanda O, Santos, Marlene, Santos, Mayler O, Satterwhite, Lewis, Saunders, Christina T, Schreiber, Jake, Schutgens, Roger EG, Seymour, Christopher W, Siegal, Deborah M, Silva, Delcio G, Singhal, Aneesh B, Slutsky, Arthur S, Solvason, Dayna, Stanworth, Simon J, Turner, Anne M, van Bentum-Puijk, Wilma, van de Veerdonk, Frank L, van Diepen, Sean, Vazquez-Grande, Gloria, Wahid, Lana, Wareham, Vanessa, Widmer, R Jay, Wilson, Jennifer G, Yuriditsky, Eugene, Zhong, Yongqi, Berry, Scott M, McArthur, Colin J, Neal, Matthew D, Hochman, Judith S, Webb, Steven A, Zarychanski, Ryan, Bradbury, Charlotte A [0000-0001-5248-8165], McVerry, Bryan J [0000-0002-1175-4874], Lawler, Patrick R [0000-0001-5155-5071], Carrier, Marc [0000-0001-8296-2972], Kim, Keri S [0000-0002-8480-4801], Houston, Brett L [0000-0002-8776-4083], Cushman, Mary [0000-0002-7871-6143], Tritschler, Tobias [0000-0002-8775-0511], Godoy, Lucas C [0000-0001-6171-1269], Gordon, Anthony C [0000-0002-0419-547X], Ahuja, Tania [0000-0003-1833-4124], Aryal, Diptesh [0000-0002-1431-8293], Baumann Kreuziger, Lisa [0000-0002-1171-0548], Beane, Abi [0000-0001-7046-1580], Coiffard, Benjamin [0000-0002-8896-5346], Detry, Michelle A [0000-0002-2794-1439], Escobedo, Jorge [0000-0003-1942-7402], Estcourt, Lise J [0000-0003-4309-9162], Everett, Brendan M [0000-0002-6331-5224], Fu, Zhuxuan [0000-0002-9190-195X], Galen, Benjamin T [0000-0001-8172-258X], Girard, Timothy D [0000-0002-9833-4871], Greenstein, Yonatan Y [0000-0002-5718-4408], Haniffa, Rashan [0000-0002-8288-449X], Hegde, Sheila M [0000-0001-8157-8899], Hendrickson, Carolyn M [0000-0003-4662-2385], Higgins, Alisa M [0000-0001-8295-7559], Hindenburg, Alexander A [0000-0002-1232-2168], Horvat, Christopher M [0000-0002-1593-2252], Huang, David T [0000-0001-7649-1633], Jacobson, Jeffrey R [0000-0001-8929-994X], Kim, Yuri [0000-0001-5978-5779], King, Andrew J [0000-0002-9809-0563], Kutcher, Matthew E [0000-0003-4566-5359], Leifer, Eric S [0000-0001-6888-8307], Litton, Edward [0000-0002-5125-6829], Mateos Garcia, Eduardo [0000-0002-0904-4056], Mouncey, Paul R [0000-0002-8510-8517], Nunez-Garcia, Brenda [0000-0002-0355-4557], Parnia, Sam [0000-0002-6158-4404], Quigley, John G [0000-0003-3116-4545], Saunders, Christina T [0000-0003-4325-9568], Yuriditsky, Eugene [0000-0003-2263-9297], Zhong, Yongqi [0000-0002-4042-7450], Neal, Matthew D [0000-0001-8931-6236], and Apollo - University of Cambridge Repository

Subjects
Male, Heparin, Critical Illness, Anticoagulants, COVID-19, Hemorrhage, Thrombosis, Middle Aged, Respiration, Artificial, COVID-19 Drug Treatment, Logistic Models, Odds Ratio, Humans, Female, Hospital Mortality, Treatment Failure, Aged
Abstract

BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

26. Supervised Exercise Training for Chronic Heart Failure With Preserved Ejection Fraction: A Scientific Statement From the American Heart Association and American College of Cardiology.

Author

Sachdev, Vandana, Sharma, Kavita, Keteyian, Steven J., Alcain, Charina F., Desvigne-Nickens, Patrice, Fleg, Jerome L., Florea, Viorel G., Franklin, Barry A., Guglin, Maya, Halle, Martin, Leifer, Eric S., Panjrath, Gurusher, Tinsley, Emily A., Wong, Renee P., and Kitzman, Dalane W.

Published
2023
Full Text
View/download PDF

28. Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials

Author

DeFilippis, Ersilia M., primary, Echols, Melvin, additional, Adamson, Philip B., additional, Batchelor, Wayne B., additional, Cooper, Lauren B., additional, Cooper, Lawton S., additional, Desvigne-Nickens, Patrice, additional, George, Richard T., additional, Ibrahim, Nasrien E., additional, Jessup, Mariell, additional, Kitzman, Dalane W., additional, Leifer, Eric S., additional, Mendoza, Martin, additional, Piña, Ileana L., additional, Psotka, Mitchell, additional, Senatore, Fortunato Fred, additional, Stein, Kenneth M., additional, Teerlink, John R., additional, Yancy, Clyde W., additional, Lindenfeld, JoAnn, additional, Fiuzat, Mona, additional, O’Connor, Christopher M., additional, Vardeny, Orly, additional, and Vaduganathan, Muthiah, additional

Published
2022
Full Text
View/download PDF

29. Assessing race and ethnicity differences in outcomes based on GDMT and target NT-proBNP in patients with heart failure with reduced ejection fraction: An analysis of the GUIDE-IT study

Author

Pahuja, Mohit, primary, Leifer, Eric S., additional, Clarke, John-Ross D., additional, Ahmad, Tariq, additional, Daubert, Melissa A., additional, Mark, Daniel B., additional, Cooper, Lawton, additional, Desvigne-Nickens, Patrice, additional, Fiuzat, Mona, additional, Adams, Kirkwood, additional, Ezekowitz, Justin, additional, Whellan, David J., additional, Januzzi, James L., additional, O'Connor, Christopher M., additional, Felker, G. Michael, additional, and Piña, Ileana L., additional

Published
2022
Full Text
View/download PDF

31. BMT CTN State of the Science Symposium 2021: Looking Forward as the Network Celebrates its 20(th) Year

Author

Heslop, Helen E, Stadtmauer, Edward A, Levine, John E, Ballen, Karen K, Chen, Yi-Bin, DeZern, Amy E, Eapen, Mary, Hamadani, Mehdi, Hamilton, Betty K, Hari, Parameswaran, Jones, Richard J, Logan, Brent R, Kean, Leslie S, Leifer, Eric S, Locke, Frederick L, Maziarz, Richard T, Nemecek, Eneida R, Pasquini, Marcelo, Phelan, Rachel, Riches, Marcie L, Shaw, Bronwen E, Walters, Mark C, Foley, Amy, Devine, Steven M, and Horowitz, Mary M

Subjects
Clinical Trials as Topic, Hematopoietic Stem Cell Transplantation, Humans, Transplants, Article, Bone Marrow Transplantation
Abstract

In 2021 the BMT CTN held the 4th State of the Science Symposium where the deliberations of 11 committees concerning major topics pertinent to a particular disease, modality, or complication of transplant, as well as two committees to consider clinical trial design and inclusion, diversity, and access as cross-cutting themes were reviewed. This article summarizes the individual committee reports and their recommendations on the highest priority questions in hematopoietic stem cell transplant and cell therapy to address in multicenter trials.

Published
2021

32. The influence of comorbidities on achieving an N‐terminal pro‐b‐type natriuretic peptide target: a secondary analysis of the GUIDE‐IT trial

Author

Ezekowitz, Justin A., primary, Alemayehu, Wendimagegn, additional, Rathwell, Sarah, additional, Grant, Andrew D., additional, Fiuzat, Mona, additional, Whellan, David J., additional, Ahmad, Tariq, additional, Adams, Kirkwood, additional, Piña, Ileana L., additional, Cooper, Lawton S., additional, Januzzi, James L., additional, Leifer, Eric S., additional, Mark, Daniel, additional, O'Connor, Christopher M., additional, and Felker, G. Michael, additional

Published
2021
Full Text
View/download PDF

36. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, Patrick R, Golighe, Ewan C, Berge, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kah, Susan RN, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Angus, Derek C, McArthur, Colin J, Webb, Steven A, Farkouh, Michael E, Hochman, Judith S, Zarychanski, Ryan, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Kreuziger, Lisa Baumann, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadzw, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Dzavik, Vladimir, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Garcia-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, Kin, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, Krishnan, Vidya, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, Le Gal, Gregoire, Leeper, Christine M, Leifer, Eric S, Lim, George, Lima, Felipe Gallego, Linstrum, Kelsey, Litton, Edward, Lopez-Sendon, Jose, Moreno, Jose L Lopez-Sendon, Lother, Sylvain A, Malhotra, Saurabh, Marcos, Miguel, Marinez, Andrea Saud, Marshall, John C, Marten, Nicole, Matthay, Michael A, McAuley, Daniel F, McDonald, Emily G, McGlothlin, Anna, McGuinness, Shay P, Middeldorp, Saskia, Montgomery, Stephanie K, Moore, Steven C, Guerreor, Raquel Morillo, Mouncey, Paul R, Murthy, Srinivas, Nair, Girish B, Nair, Rahul, Nichol, Alistair D, Nunez-Garcia, Brenda, Pandey, Ambarish, Park, Pauline K, Parke, Rachael L, Parker, Jane C, Parnia, Sam, Paul, Jonathan D, Gonzalez, Yessica S Perez, Pompilio, Mauricio, Prekker, Matthew E, Quigley, John G, Rost, Natalia S, Rowan, Kathryn, Santos, Fernanda O, Santos, Marlene, Santos, Mayler Olombrada, Satterwhite, Lewis, Saunders, Christina T, Schutgens, Roger EG, Seymour, Christopher W, Siegal, Deborah M, Jr, Silva Delcio G, Shankar-Hari, Manu, Sheehan, John P, Singhal, Aneesh B, Solvaso, Dayna, Stanworth, Simon J, Tritschler, Tobias, Turner, Anne M, Van Bentum-Puijk, Wilma, van de Veerdonk, Frank L, van Diepen, Sean, Vazquez-Grande, Gloria, Wahid, Lana, Wareham, Vanessa, Wells, Bryan J, Widmer, R Jay, Wilson, Jennifer G, Yuriditsky, Eugene, Zampieri, Fernando G, Investigators, ATTACC, Investigators, ACTIV-4a, Investigators, REMAP-CAP, Investigators, ATTACC, Investigators, ACTIV-4a, Investigators, REMAP-CAP, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), 215522, AR7-162822, CS-2016-16-011, RP-2015-06-18, National Institutes of Health, NIH: 1OT2HL156812-01, OTA-20-011, UL1TR001445, National Heart, Lung, and Blood Institute, NHLBI, Breast Cancer Research Foundation, BCRF, National Center for Advancing Translational Sciences, NCATS, New York University, NYU, Medical Center, University of Pittsburgh, CancerCare Manitoba Foundation, CCMF, University of Manitoba, UM, Health Research Board, HRB: CTN 2014-012, Canadian Institutes of Health Research, CIHR, National Institute for Health Research, NIHR, European Commission, EC: 602525, FP7-HEALTH-2013-INNOVATION, National Health and Medical Research Council, NHMRC: APP1101719, APP1116530, Health Research Council of New Zealand, HRC: 158584, 16/631, 447335, Canada Research Chairs, Eisai, Ministère des Affaires Sociales et de la Santé: PHRC-20-0147, Horizon 2020: 101003589, NIHR Imperial Biomedical Research Centre, BRC, Minderoo Foundation, The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, Peter Munk Cardiac Centre, CancerCare Manitoba Foundation, and Victoria General Hospital Foundation. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health (NIH) (grant numbers, OTA-20-011 and 1OT2HL156812-01). The pilot program (PROTECT) was funded in part by a grant (UL1TR001445) from the New York University Clinical and Translational Science Award program, supported by the National Center for Advancing Translational Sciences of the NIH. The REMAP-CAP platform was supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525) and the Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589), by the Australian National Health and Medical Research Council (APP1101719 and APP1116530), the Health Research Council of New Zealand (16/631), the Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant [158584] and Covid-19 Rapid Research Operating Grant [447335]), the U.K. National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the Learning While Doing Program at the University of Pittsburgh Medical Center, the Breast Cancer Research Foundation, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Am-gen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). Dr. Goligher is the recipient of an Early Career Investigator award from the Canadian Institutes of Health Research (grant AR7-162822). Dr. Gordon is supported by an NIHR Research Professorship (RP-2015-06-18), Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011), and Dr. Turgeon by a Canada Research Chair (Tier 2). Dr. Zarychanski is the recipient of the Lyonel G. Israels Research Chair in Hematology (University of Manitoba)., Listed are data that were included in the analysis involving patients with moderate severity of coronavirus disease 2019 (Covid-19). The denominators of patients in the anticoagulation group and the thrombophylaxis group are un-equal owing to response-adaptive randomization. The baseline characteristics of the patients according to d-dimer level are provided in Table S2 in the Supplementary Appendix. To convert the values for creatinine to micromoles per liter, multiply by 88.4. ULN denotes upper limit of the normal range. † Race or ethnic group was reported by the patients. ‡ The body-mass index is the weight in kilograms divided by the square of the height in meters. § Severe cardiovascular disease was defined as a baseline history of heart failure, myocardial infarction, coronary artery disease, peripheral arterial disease, or cerebrovascular disease (stroke or transient ischemic attack) in the ATTACC (Antithrombotic Therapy to Ameliorate Complications of Covid-19) and ACTIV-4a (A Multicenter, Adaptive, Ran-domized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19) platforms and as a baseline history of New York Heart Association class IV symptoms in the REMAP-CAP platform (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia). ¶ Chronic respiratory disease was defined as a baseline history of asthma, chronic obstructive pulmonary disease, bron-chiectasis, interstitial lung disease, primary lung cancer, pulmonary hypertension, active tuberculosis, or the receipt of home oxygen therapy. ‖ Not listed are 74 patients who were coenrolled in the REMAP-CAP Antiplatelet Domain (39 in the anticoagulation group and 35 in the thromboprophylaxis group). ** In REMAP-CAP, levels of oxygen support (including no support) below the level of high-flow nasal cannula were not reported. †† The relative proportion of patients who were randomly assigned in each platform was imbalanced owing to imple-mentation of response-adaptive randomization in ATTACC on December 15, 2020. ‡‡ A total of 215 patients who were enrolled in the ATTACC platform were funded by the ACTIV4a platform by the National Heart, Lung, and Blood Institute. §§ Other participating countries were Mexico, Nepal, Australia, the Netherlands, and Spain., ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Lawler, Patrick R [0000-0001-5155-5071], Neal, Matthew D [0000-0001-8931-6236], McVerry, Bryan J [0000-0002-1175-4874], Carrier, Marc [0000-0001-8296-2972], Escobedo, Jorge [0000-0003-1942-7402], Huang, David T [0000-0001-7649-1633], Bradbury, Charlotte A [0000-0001-5248-8165], Houston, Brett L [0000-0002-8776-4083], Kornblith, Lucy Z [0000-0002-1861-9691], Kim, Keri S [0000-0002-8480-4801], Gordon, Anthony C [0000-0002-0419-547X], Higgins, Alisa M [0000-0001-8295-7559], Aday, Aaron W [0000-0001-6243-3432], Aryal, Diptesh [0000-0002-1431-8293], Baumann Kreuziger, Lisa [0000-0002-1171-0548], Beane, Abi [0000-0001-7046-1580], Coiffard, Benjamin [0000-0002-8896-5346], Derde, Lennie PG [0000-0002-3577-5629], Detry, Michelle A [0000-0002-2794-1439], Estcourt, Lise J [0000-0003-4309-9162], Everett, Brendan M [0000-0002-6331-5224], Galen, Benjamin T [0000-0001-8172-258X], Girard, Timothy D [0000-0002-9833-4871], Godoy, Lucas C [0000-0001-6171-1269], Greenstein, Yonatan Y [0000-0002-5718-4408], Haniffa, Rashan [0000-0002-8288-449X], Hanna, George [0000-0001-8737-3843], Hegde, Sheila M [0000-0001-8157-8899], Hendrickson, Carolyn M [0000-0003-4662-2385], Hite, R Duncan [0000-0002-2625-8750], Hindenburg, Alexander A [0000-0002-1232-2168], Horvat, Christopher M [0000-0002-1593-2252], Jacobson, Jeffrey R [0000-0001-8929-994X], Kim, Yuri [0000-0001-5978-5779], King, Andrew J [0000-0002-9809-0563], Kutcher, Matthew E [0000-0003-4566-5359], Lima, Felipe Gallego [0000-0003-1204-5743], Lopez-Sendon Moreno, Jose L [0000-0001-9414-3990], Marcos, Miguel [0000-0003-1269-4487], McGlothlin, Anna [0000-0002-9079-6166], Mouncey, Paul R [0000-0002-8510-8517], Nunez-Garcia, Brenda [0000-0002-0355-4557], Parnia, Sam [0000-0002-6158-4404], Quigley, John G [0000-0003-3116-4545], Saunders, Christina T [0000-0003-4325-9568], Shankar-Hari, Manu [0000-0002-5338-2538], Sheehan, John P [0000-0002-4328-2613], Tritschler, Tobias [0000-0002-8775-0511], Yuriditsky, Eugene [0000-0003-2263-9297], Zampieri, Fernando G [0000-0001-9315-6386], Angus, Derek C [0000-0002-7026-5181], Apollo - University of Cambridge Repository, NIHR, and National Institute for Health Research

Subjects
Male, covid-19, anticoagulation, [SDV]Life Sciences [q-bio], lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], 030204 cardiovascular system & hematology, heparin, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Hemorrhage/chemically induced, 030212 general & internal medicine, Hospital Mortality, Heparin/administration & dosage, anticoagulation, 11 Medical and Health Sciences, Anticoagulants/administration & dosage, Thrombosis/prevention & control, low molecular weight heparin, General Medicine, Heparin, Middle Aged, Thrombosis, Patient Discharge, 3. Good health, Coagulation, Original Article, Female, ATTACC Investigators, medicine.symptom, Covid-19, Life Sciences & Biomedicine, medicine.drug, Adult, medicine.medical_specialty, medicine.drug_class, adaptive platform trial, Low molecular weight heparin, Inflammation, Hemorrhage, COVID-19/drug therapy, 03 medical and health sciences, Medicine, General & Internal, General & Internal Medicine, medicine, Humans, Intensive care medicine, Survival analysis, Aged, Science & Technology, business.industry, SARS-CoV-2, Anticoagulants, COVID-19, Odds ratio, Heparin, Low-Molecular-Weight, medicine.disease, Survival Analysis, COVID-19 Drug Treatment, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Heparin, Low-Molecular-Weight/therapeutic use, ACTIV-4a Investigators, Human medicine, REMAP-CAP Investigators, business
Abstract

BACKGROUNDThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.METHODSIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care–level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.RESULTSThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support–free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.CONCLUSIONSIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589. opens in new tab, NCT04505774. opens in new tab, NCT02735707. opens in new tab, and NCT04359277. opens in new tab.)

Published
2021
Full Text
View/download PDF

37. sj-pdf-1-ctj-10.1177_17407745211014493 – Supplemental material for Joint testing of overall and simple effects for the two-by-two factorialtrial design

Author

Leifer, Eric S, Troendle, James F, Kolecki, Alexis, and Follmann, Dean A

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-pdf-1-ctj-10.1177_17407745211014493 for Joint testing of overall and simple effects for the two-by-two factorialtrial design by Eric S Leifer, James F Troendle, Alexis Kolecki and Dean A Follmann in Clinical Trials

Published
2021
Full Text
View/download PDF

39. Reproducibility of Peak Oxygen Uptake and Other Cardiopulmonary Exercise Testing Parameters in Patients With Heart Failure (from the Heart Failure and A Controlled Trial Investigating Outcomes of exercise traiNing)

Author

Bensimhon, Daniel R., Leifer, Eric S., Ellis, Stephen J., Fleg, Jerome L., Keteyian, Steven J., Piña, Ileana L., Kitzman, Dalane W., McKelvie, Robert S., Kraus, William E., Forman, Daniel E., Kao, Andrew J., Whellan, David J., O'Connor, Christopher M., and Russell, Stuart D.

Published
2008
Full Text
View/download PDF

41. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

Author

O'Connor, Christopher M., Whellan, David J., Lee, Kerry L., Keteyian, Steven J., Cooper, Lawton S., Ellis, Stephen J., Leifer, Eric S., Kraus, William E., Kitzman, Dalana W., Blumenthal, James A., Rendall, David S., Miller, Nancy Houston, Fleg, Jerome L., Schulman, Kevin A., McKelvie, Robert S., Zannad, Faiez, and Pina, Deana L.

Subjects
Heart failure -- Prevention, Heart failure -- Research, Cardiac patients -- Physiological aspects, Cardiac patients -- Health aspects, Exercise -- Usage, Exercise -- Health aspects
Abstract

A study was conducted to evaluate the efficacy and safety of using exercise training in improving the condition of patients with chronic heart failure. Results indicated that exercise training was effective in modest significant reductions in hospitalization and mortality associated with cardiac failure.

Published
2009

42. Conduct of clinical trials in the era of COVID-19: JACC scientific expert panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Bhatt, Ankeet S, Carson, Peter E, Cleland, John G.F., Felker, G Michael, Januzzi, James L, Kitzman, Dalane W, Leifer, Eric S, Lewis, Eldrin F, McMurray, John J.V., Mentz, Robert J, Solomon, Scott D, Stockbridge, Norman, Teerlink, John R, Vaduganathan, Muthiah, Vardeny, Orly, Whellan, David J, Wittes, Janet, Anker, Stefan D, and O'Connor, Christopher M

Subjects
R1
Abstract

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.

Published
2020

43. Heart Failure and A Controlled Trial Investigating Outcomes of Exercise traiNing (HF-ACTION): design and rationale

Author

Whellan, David J., O'Connor, Christopher M., Lee, Kerry L., Keteyian, Steven J., Cooper, Lawton S., Ellis, Stephen J., Leifer, Eric S., Kraus, William E., Kitzman, Dalane W., Blumenthal, James A., Rendall, David S., Houston-Miller, Nancy, Fleg, Jerome L., Schulman, Kevin A., and Pina, Ileana L.

Subjects
Experimental design -- Evaluation, Heart failure -- Research, Cardiovascular research -- Evaluation, Health
Published
2007

48. Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial

Author

Fiuzat, Mona, primary, Ezekowitz, Justin, additional, Alemayehu, Wendimagegn, additional, Westerhout, Cynthia M., additional, Sbolli, Marco, additional, Cani, Dario, additional, Whellan, David J., additional, Ahmad, Tariq, additional, Adams, Kirkwood, additional, Piña, Ileana L., additional, Patel, Chetan B., additional, Anstrom, Kevin J., additional, Cooper, Lawton S., additional, Mark, Daniel, additional, Leifer, Eric S., additional, Felker, G. Michael, additional, Januzzi, James L., additional, and O’Connor, Christopher M., additional

Published
2020
Full Text
View/download PDF

49. Randomized multicenter trial of sirolimus vs prednisone as initial therapy for standard-risk acute GVHD: the BMT CTN 1501 trial

Author

Pidala, Joseph, primary, Hamadani, Mehdi, additional, Dawson, Peter, additional, Martens, Michael, additional, Alousi, Amin M., additional, Jagasia, Madan, additional, Efebera, Yvonne A., additional, Chhabra, Saurabh, additional, Pusic, Iskra, additional, Holtan, Shernan G., additional, Ferrara, James L. M., additional, Levine, John E., additional, Mielcarek, Marco, additional, Anasetti, Claudio, additional, Antin, Joseph H., additional, Bolaños-Meade, Javier, additional, Howard, Alan, additional, Logan, Brent R., additional, Leifer, Eric S., additional, Pritchard, Theresa S., additional, Horowitz, Mary M., additional, and MacMillan, Margaret L., additional

Published
2020
Full Text
View/download PDF

50. Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial

Author

OʼConnor, Christopher M., Whellan, David J., Lee, Kerry L., Keteyian, Steven J., Cooper, Lawton S., Ellis, Stephen J., Leifer, Eric S., Kraus, William E., Kitzman, Dalane W., Blumenthal, James A., Rendall, David S., Miller, Nancy Houston, Fleg, Jerome L., Schulman, Kevin A., McKelvie, Robert S., Zannad, Faiez, and Piña, Ileana L.

Published
2009
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results