Search

Your search keyword '"Leifer, Eric S"' showing total 177 results
Start Over Author "Leifer, Eric S" Publication Year Range Last 10 years
177 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

12. 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

14. 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

17. 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

18. 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

22. 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

23. 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

24. 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

25. 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

26. 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

28. 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

29. 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

31. 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

32. 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

33. 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

35. 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

36. 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

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

Subjects
NATRIURETIC peptides, HEART failure, ATRIAL fibrillation
Abstract

Aims: N‐terminal pro‐b‐type natriuretic peptide (NT‐proBNP) values may be influenced by patient factors beyond the severity of illness, including atrial fibrillation (AF), renal dysfunction, or increased body mass index (BMI). We hypothesized that these factors may influence the achievement of NT‐proBNP targets and clinical outcomes. Methods: A total of 894 patients with heart failure with reduced ejection fraction were enrolled in The Guiding Evidence‐Based Therapy Using Biomarker Intensified Treatment trial. NT‐proBNP was analysed every 3 months. Results: Forty per cent of patients had AF, the median estimated glomerular filtration rate (eGFR) was 59 mL/min/1.73 m2 [interquartile range (IQR) 43–76], and median BMI was 29 kg/m2 (IQR 25–34). Patients with AF, eGFR < 60 mL/min/1.73 m2, or a BMI < 29 kg/m2 had a higher level of NT‐proBNP at randomization and over all study visits (all P values < 0.001). Over 18 months, the rate of change of NT‐proBNP was less for patients with AF (compared with those without AF, P = 0.037) and patients with an eGFR < 60 mL/min/1.73 m2 (compared with eGFR > 60 mL/min/1.73 m2, P < 0.001). The rate of change of NT‐proBNP was similar for patients with a BMI above or below the median value. Using the 90 day NT‐proBNP, patients with AF, lower eGFR, or lower BMI were less likely to achieve the target NT‐proBNP < 1000 pg/mL than patients without AF, higher eGFR, or higher BMI, respectively. None of these differed between the Usual Care or Guided Care arm for AF, eGFR, or BMI (Pinteractions all NS). Conclusions: Patients with AF, a lower BMI, or worse renal function are less likely to achieve a lower or target NT‐proBNP. Clinicians should be aware of these factors both when interpreting NT‐proBNP levels and making therapeutic decisions about heart failure therapies. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

39. Clinical factors related to morbidity and mortality in high‐risk heart failure patients: the GUIDE‐IT predictive model and risk score

Author

O'Connor, Christopher, primary, Fiuzat, Mona, additional, Mulder, Hillary, additional, Coles, Adrian, additional, Ahmad, Tariq, additional, Ezekowitz, Justin A., additional, Adams, Kirkwood F., additional, Piña, Ileana L., additional, Anstrom, Kevin J., additional, Cooper, Lawton S., additional, Mark, Daniel B., additional, Whellan, David J., additional, Januzzi, James L., additional, Leifer, Eric S., additional, and Felker, G. Michael, additional

Published
2019
Full Text
View/download PDF

41. How to Control for Unmeasured Confounding in an Observational Time-To-Event Study With Exposure Incidence Information: The Treatment Choice Cox Model

Author

Troendle, James F., Leifer, Eric S., Zhang, Zhiwei, Yang, Song, and Tewes, Heather

Subjects
Postmenopause, Observational Studies as Topic, Treatment Outcome, Bias, Hormone Replacement Therapy, Incidence, Humans, Computer Simulation, Confounding Factors, Epidemiologic, Female, Article, Proportional Hazards Models
Abstract

In an observational study of the effect of a treatment on a time-to-event outcome, a major problem is accounting for confounding because of unknown or unmeasured factors. We propose including covariates in a Cox model that can partially account for an unknown time-independent frailty that is related to starting or stopping treatment as well as the outcome of interest. These covariates capture the times at which treatment is started or stopped and so are called treatment choice (TC) covariates. Three such models are developed: first, an interval TC model that assumes a very general form for the respective hazard functions of starting treatment, stopping treatment, and the outcome of interest and second, a parametric TC model that assumes that the log hazard functions for starting treatment, stopping treatment, and the outcome event include frailty as an additive term. Finally, a hybrid TC model that combines attributes from the parametric and interval TC models. As compared with an ordinary Cox model, the TC models are shown to substantially reduce the bias of the estimated hazard ratio for treatment when data are simulated from a realistic Cox model with residual confounding due to the unobserved frailty. The simulations also indicate that the bias decreases or levels off as the sample size increases. A TC model is illustrated by analyzing the Women's Health Initiative Observational Study of hormone replacement for post-menopausal women. Published 2017. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

Published
2017

44. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

Author

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

Abstract

Importance: The natriuretic peptides are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels ("guided therapy") with inconsistent results. Objective: To determine whether an amino-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided treatment strategy improves clinical outcomes vs usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). Design, Settings, and Participants: The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multicenter clinical trial conducted between January 16, 2013, and September 20, 2016, at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNP-guided strategy or usual care. Interventions: Patients were randomized to either an NT-proBNP-guided strategy or usual care. Patients randomized to the guided strategy (n = 446) had HF therapy titrated with the goal of achieving a target NT-proBNP of less than 1000 pg/mL. Patients randomized to usual care (n = 448) had HF care in accordance with published guidelines, with emphasis on titration of proven neurohormonal therapies for HF. Serial measurement of NT-proBNP testing was discouraged in the usual care group. Main Outcomes and Measures: The primary end point was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary end points included all-cause mortality, total hospitalizations for HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary end point, and adverse events. Results: The data and safety monitoring board recommended stopping the study for futility w

Published
2017

45. Effect of Natriuretic Peptide-Guided Therapy on Outcomes in High-Risk Patients with Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial

Author

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

Published
2017
Full Text
View/download PDF

47. Effect of Natriuretic Peptide–Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction

Author

Felker, G. Michael, primary, Anstrom, Kevin J., additional, Adams, Kirkwood F., additional, Ezekowitz, Justin A., additional, Fiuzat, Mona, additional, Houston-Miller, Nancy, additional, Januzzi, James L., additional, Mark, Daniel B., additional, Piña, Ileana L., additional, Passmore, Gayle, additional, Whellan, David J., additional, Yang, Hongqiu, additional, Cooper, Lawton S., additional, Leifer, Eric S., additional, Desvigne-Nickens, Patrice, additional, and O’Connor, Christopher M., additional

Published
2017
Full Text
View/download PDF

49. Psychosocial Factors, Exercise Adherence, and Outcomes in Heart Failure Patients

Author

Cooper, Lauren B., primary, Mentz, Robert J., additional, Sun, Jie-Lena, additional, Schulte, Phillip J., additional, Fleg, Jerome L., additional, Cooper, Lawton S., additional, Piña, Ileana L., additional, Leifer, Eric S., additional, Kraus, William E., additional, Whellan, David J., additional, Keteyian, Steven J., additional, and O’Connor, Christopher M., additional

Published
2015
Full Text
View/download PDF

50. Statistical Design Features of the Healthy Communities Study

Author

Strauss, Warren J., primary, Sroka, Christopher J., additional, Frongillo, Edward A., additional, Sonia Arteaga, S., additional, Loria, Catherine M., additional, Leifer, Eric S., additional, Wu, Colin O., additional, Patrick, Heather, additional, Fishbein, Howard A., additional, and John, Lisa V., additional

Published
2015
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results