Relationship Between Clinical Trial Site Enrollment With Participant Characteristics, Protocol Completion, and Outcomes
Open accessAbstract
Objectives The study investigated whether the number of participants enrolled per site in an acute heart failure trial is associated with participant characteristics and outcomes.Background Whether and how site enrollment volume affects clinical trials is not known.Methods A total of 4,133 participants enrolled among 359 sites were grouped on the basis of total enrollment into 1 to 10, 11 to 30, and >30 participants per site and were compared for outcomes (cardiovascular mortality or heart failure hospitalization).Results Per-site enrollment ranged from 0 to 75 (median 6; 77 sites had no enrollment). Regional differences in enrollment were noted between North and South America, and Western and Eastern Europe (p < 0.001). Participants from sites with fewer enrollments were more likely to be older and male, have lower ejection fraction and blood pressure as well as worse comorbidity and laboratory profile, and were less likely to be on angiotensin-converting enzyme inhibitors or aldosterone antagonists. During a median follow-up of 9.9 months, 1,700 (41%) participants had an outcome event. Compared to event rate at sites with >30 participants (32%), those with 1 to 10 (51%, hazard ratio [HR]: 1.77, 95% confidence interval [CI]: 1.56 to 2.02) and 11 to 30 (42%, HR: 1.44, 95% CI: 1.28 to 1.62) participants per site groups had worse outcomes. This relationship was comparable across regions (p = 0.43). After adjustment for risk factors, participants enrolled at sites with fewer enrollees were at higher risk for adverse outcomes (HR: 1.26, 95% CI: 1.08 to 1.46 for 1 to 10; HR: 1.22, 95% CI: 1.07 to 1.38 for 11 to 30 vs. >30 participant sites). Higher proportion of participants from site with >30 participants completed the protocol (45.5% for <10, 61.7% for 11 to 30, and 68.4% for sites enrolling >30 participants; p < 0.001).Conclusions Baseline characteristics, protocol completion, and outcomes differed significantly among higher versus lower enrolling sites. These data imply that the number of participant enrolled per site may influence trials beyond logistics.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.
“International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.19–32”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [27]
The reasons for discordant US results range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.
“The reasons range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [27]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Heart Disease and Stroke Statistics—2012 Update: A Report From the American Heart Association
Writing Group Members, Roger, V. L., Go, A. S., Lloyd-Jones, D. M., Benjamin, E. J., Berry, J. D., Borden, W. B., Bravata, D. M., Dai, S., Ford, E. S., et al. (2012) · Circulation · doi:10.1161/cir.0b013e31823ac046 · Cited by 7,333 · see citing works
Heart Disease and Stroke Statistics—2010 Update: A Report From the American Heart Association
WRITING GROUP MEMBERS, Lloyd-Jones, D., Adams, R. J., Brown, T. M., Carnethon, M., Dai, S., De Simone, G., Ferguson, T. B., Ford, E., Furie, K., et al. (2010) · Circulation · doi:10.1161/circulationaha.109.192667 · Cited by 5,700 · see citing works
HEART DISEASE AND STROKE STATISTICS–2014 UPDATE: A REPORT FROM THE AMERICAN HEART ASSOCIATION
Tarver, T. (2014) · Journal of Consumer Health on the Internet · doi:10.1080/15398285.2014.902284 · Cited by 5,595 · see citing works
The price of innovation: new estimates of drug development costs
DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003) · Journal of Health Economics · doi:10.1016/s0167-6296(02)00126-1 · Cited by 4,265 · see citing works
Bhatt, D. L. (2006) · JAMA · doi:10.1001/jama.295.2.180 · Cited by 1,628 · see citing works
Konstam, M. A. (2007) · JAMA · doi:10.1001/jama.297.12.1319 · Cited by 1,628 · see citing works
Self-citationGheorghiade, M. (2007) · JAMA · doi:10.1001/jama.297.12.1332 · Cited by 841 · see citing works
Self-citationGheorghiade, M., Zannad, F. M., Sopko, G. S., Klein, L., Piña, I. L., Konstam, M. A., Massie, B. M., Roland, E., Targum, S. L., Collins, S. P., et al. (2005) · Circulation · doi:10.1161/circulationaha.105.590091 · Cited by 788 · see citing works
Self-citationChen, J., Normand, S. T., Wang, Y., & Krumholz, H. M. (2011) · JAMA · doi:10.1001/jama.2011.1474 · Cited by 742 · see citing works
Ethical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710 · see citing works
Goldstein, D. B., Tate, S. K., & Sisodiya, S. M. (2003) · Nature Reviews Genetics · doi:10.1038/nrg1229 · Cited by 312 · see citing works
Rebuilding the R&D engine in big pharma.
Garnier, J.-P. (2008) · PubMed · Cited by 227 · see citing works
Blair, J. E., Zannad, F. M., Konstam, M. A., Cook, T. D., Traver, B., Burnett, J. C. J., Grinfeld, L. R., Krasa, H. B., Maggioni, A. P., Orlandi, C., et al. (2008) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2008.07.056 · Cited by 172 · see citing works
Self-citationGheorghiade, M., Orlandi, C., Burnett, J. C. J., DeMets, D. L., Grinfeld, L. R., Maggioni, A. P., Swedberg, K. B., Udelson, J. E., Zannad, F. M., Zimmer, C., et al. (2005) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2005.03.009 · Cited by 171 · see citing works
Self-citationLarson, H. N., Zhou, J., Chen, Z., Stamler, J. S., Weiner, H., & Hurley, T. D. (2007) · Journal of Biological Chemistry · doi:10.1074/jbc.m607959200 · Cited by 111 · see citing works
Bristow, M. R., Murphy, G. A., Krause-Steinrauf, H. J., Anderson, J. L., Carlquist, J. F., Thaneemit-Chen, S., Krishnan, V., Abraham, W. T., Lowes, B. D., Port, J. D., et al. (2009) · Circulation Heart Failure · doi:10.1161/circheartfailure.109.885962 · Cited by 111 · see citing works
Seitz, H. K., Matsuzaki, S., Yokoyama, A., Homann, N., Vakevainen, S. M., & Wang, X. D. (2001) · Alcoholism Clinical and Experimental Research · doi:10.1111/j.1530-0277.2001.tb02388.x · Cited by 99 · see citing works
Influence of Global Region on Outcomes in Heart Failure Beta-Blocker Trials
O’Connor, C. M., Fiuzat, M., Swedberg, K. B., Caron, M. F., Koch, B., Carson, P. E., Gattis‐Stough, W., Davis, G. W., & Bristow, M. R. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.03.057 · Cited by 73 · see citing works
Self-citationCollins, S. P., Pang, P. S., Lindsell, C. J., Kyriacou, D. N., Storrow, A. B., Hollander, J. E., Kirk, J. D., Miller, C. D., Nowak, R. M., Peacock, W. F., et al. (2010) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfq133 · Cited by 59 · see citing works
Self-citationMassie, B. M., Cleland, J. G. F., Armstrong, P. W., Packer, M., Poole-Wilson, P. A., & Lars, R. (1998) · Journal of Cardiac Failure · doi:10.1016/s1071-9164(98)90502-4 · Cited by 40 · see citing works
Gheorghiade, M., Pang, P. S., O’Connor, C. M., Prasad, K., McMurray, J. J. V., Teerlink, J. R., Fiuzat, M., Sabbah, H. N., & Michel Komajda, N. (2010) · American Heart Journal · doi:10.1016/j.ahj.2010.10.023 · Cited by 39 · see citing works
Self-citationPitt, B., Zannad, F. M., Gheorghiade, M., Martínez, F. A., Love, T. E., Daniel, C., & Ahmed, A. (2009) · International Journal of Cardiology · doi:10.1016/j.ijcard.2009.03.036 · Cited by 22 · see citing works
Self-citationA Review of Phase II Acute Heart Failure Syndromes Clinical Trials
Pang, P. S., & Gheorghiade, M. (2011) · Heart Failure Clinics · doi:10.1016/j.hfc.2011.06.002 · Cited by 7 · see citing works
Self-citation
Flagged first, then by citations
1 of the 24 references couldn’t be matched to a known paper.
Research works printed but not linked: 1
- Truelove C. 21st Annual report: belt tightens on big pharma. Med Ad News 2007;26:4 -7.
Cited by
Sorted by citations
The Global Health and Economic Burden of Hospitalizations for Heart Failure
Ambrosy, A. P., Fonarow, G. C., Butler, J., Chioncel, O., Greene, S. J., Vaduganathan, M., Nodari, S., Lam, C. S. P., Sato, N., Shah, A. N., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.11.053 · Cited by 2,055 · see citing works
Self-citationREDUCE-IT USA: Results From the 3146 Patients Randomized in the United States
Bhatt, D. L., Miller, M., Brinton, E. A., Jacobson, T. A., Steg, P. G., Ketchum, S. B., Doyle, R. T., Juliano, R. A., Jiao, L., Granowitz, C., et al. (2020) · Circulation · doi:10.1161/circulationaha.119.044440 · Cited by 136 · see citing works
Good Clinical Practice Guidance and Pragmatic Clinical Trials
Mentz, R. J., Hernandez, A. F., Berdan, L. G., Rorick, T. L., O'Brien, E. C., Ibarra, J. C., Curtis, L. H., & Peterson, E. D. (2016) · Circulation · doi:10.1161/circulationaha.115.019902 · Cited by 119 · see citing works
Self-citationRegistry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions
Lund, L. H., Oldgren, J., & James, S. K. (2017) · Current Heart Failure Reports · doi:10.1007/s11897-017-0325-0 · Cited by 89 · see citing works
Mentz, R. J., Cotter, G., Cleland, J. G. F., Stevens, S. R., Chiswell, K., Davison, B. A., Teerlink, J. R., Metra, M., Voors, A. A., Grinfeld, L. R., et al. (2014) · European Journal of Heart Failure · doi:10.1002/ejhf.92 · Cited by 77 · see citing works
Self-citationGeographic Differences in Heart Failure Trials
Ferreira, J. P., Girerd, N., Rossignol, P., & Zannad, F. M. (2015) · European Journal of Heart Failure · doi:10.1002/ejhf.326 · Cited by 73 · see citing works
Self-citationGreene, S. J., Fonarow, G. C., Solomon, S. D., Subacius, H. P., Maggioni, A. P., Böhm, M., Lewis, E. F., Zannad, F. M., Gheorghiade, M., & for the ASTRONAUT Investigators and Coordinators (2015) · European Journal of Heart Failure · doi:10.1002/ejhf.280 · Cited by 65 · see citing works
Self-citationAmbrosy, A., Gheorghiade, M., Chioncel, O., Mentz, R., & Butler, J. (2014) · Current Heart Failure Reports · doi:10.1007/s11897-014-0221-9 · Cited by 51 · see citing works
Self-citationWong, T. C., Piehler, K. M., Zaręba, K. M., Lin, K., Phrampus, A., Patel, A. D., Moon, J., Ugander, M., Valeti, U. S., Holtz, J. E., et al. (2013) · Journal of the American Heart Association · doi:10.1161/jaha.113.000416 · Cited by 48 · see citing works
Self-citationRecognizing Hospitalized Heart Failure as an Entity and Developing New Therapies to Improve Outcomes
Gheorghiade, M., Shah, A. N., Vaduganathan, M., Butler, J., Bonow, R. O., Rosano, G. M. C., Taylor, S., Kupfer, S., Misselwitz, F., Sharma, A. N., et al. (2013) · Heart Failure Clinics · doi:10.1016/j.hfc.2013.05.002 · Cited by 46 · see citing works
Self-citationPragmatic Design of Randomized Clinical Trials for Heart Failure
Greene, S. J., Velazquez, E. J., Anstrom, K. J., Eisenstein, E. L., Sapp, S. K., Morgan, S., Harding, T. M., Sachdev, V., Ketema, F., Kim, D., et al. (2021) · JACC Heart Failure · doi:10.1016/j.jchf.2021.01.013 · Cited by 41 · see citing works
Self-citationModeling human immune responses to vaccination in vitro
Morrocchi, E., van Haren, S. D., Palma, P., & Levy, O. (2023) · Trends in Immunology · doi:10.1016/j.it.2023.11.002 · Cited by 39 · see citing works
Greene, S. J., Shah, A. N., Butler, J., Ambrosy, A. P., Anker, S. D., Chioncel, O., Collins, S. P., Dinh, W., Dunnmon, P. M., Fonarow, G. C., et al. (2014) · American Heart Journal · doi:10.1016/j.ahj.2014.05.009 · Cited by 35 · see citing works
Self-citationLearning from recent trials and shaping the future of acute heart failure trials
Mentz, R. J., Felker, G. M., Ahmad, T., Peacock, W. F., Pitt, B., Fiuzat, M., Maggioni, A. P., Gheorghiade, M., Ando, Y., Pocock, S., et al. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.08.001 · Cited by 32 · see citing works
Self-citationTrends in characteristics of cardiovascular clinical trials 2001-2012
Butler, J., Tahhan, A. S., Georgiopoulou, V. V., Kelkar, A. A., Lee, M., Khan, B., Peterson, E. D., Fonarow, G. C., Kalogeropoulos, A. P., & Gheorghiade, M. (2015) · American Heart Journal · doi:10.1016/j.ahj.2015.05.006 · Cited by 31 · see citing works
Self-citationHead, S. J., Parasca, C. A., Mack, M. J., Mohr, F. W., Morice, M., Holmes, D. R., Feldman, T. E., Dawkins, K. D., Colombo, A., Serruys, P. W. J. C., et al. (2014) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezu197 · Cited by 29 · see citing works
Trends in Heart Failure Clinical Trials From 2001–2012
Tahhan, A. S., Vaduganathan, M., Kelkar, A. A., Georgiopoulou, V. V., Kalogeropoulos, A. P., Greene, S. J., Fonarow, G. C., Gheorghiade, M., & Butler, J. (2015) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2015.06.014 · Cited by 24 · see citing works
Self-citationButler, J., Fonarow, G. C., O’Connor, C. M., Adams, K. F., Bonow, R. O., Cody, R. J., Collins, S. P., Dunnmon, P. M., Dinh, W., Fiuzat, M., et al. (2014) · American Heart Journal · doi:10.1016/j.ahj.2014.12.001 · Cited by 23 · see citing works
Self-citationVaduganathan, M., Tahhan, A. S., Greene, S. J., Okafor, M. O., Kumar, S., & Butler, J. (2018) · European Journal of Heart Failure · doi:10.1002/ejhf.1130 · Cited by 23 · see citing works
Self-citationMilojevic, M., Head, S. J., Mack, M. J., Mohr, F. W., Morice, M., Dawkins, K. D., Holmes, D. R., Serruys, P. W. J. C., & Kappetein, A. P. (2017) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezx104 · Cited by 21 · see citing works
Greene, S. J., Hernandez, A. F., Sun, J., Metra, M., Butler, J., Ambrosy, A. P., Ezekowitz, J. A., Starling, R. C., Teerlink, J. R., Schulte, P. J., et al. (2016) · Circulation Heart Failure · doi:10.1161/circheartfailure.116.002986 · Cited by 20 · see citing works
Self-citationAcute Heart Failure: Lessons Learned, Roads Ahead
Ferrari, R., Bueno, H., Chioncel, O., Cleland, J. G. F., Stough, W. G., Lettino, M., Metra, M., Parissis, J., Pinto, F. J., Ponikowski, P. P., et al. (2018) · European Journal of Heart Failure · doi:10.1002/ejhf.1169 · Cited by 19 · see citing works
Geographic Variation in Heart Failure Trials: Time for Scepticism?
Pitt, B., & Gheorghiade, M. (2014) · European Journal of Heart Failure · doi:10.1002/ejhf.112 · Cited by 18 · see citing works
Self-citationSite selection for heart failure clinical trials in the USA
Harinstein, M. E., Butler, J., Greene, S. J., Fonarow, G. C., Stockbridge, N., O’Connor, C. M., Pfeffer, M. A., Mehra, M. R., Solomon, S. D., Yancy, C. W., et al. (2015) · Heart Failure Reviews · doi:10.1007/s10741-015-9473-z · Cited by 17 · see citing works
Self-citationStrategies to Prevent Postdischarge Adverse Events Among Hospitalized Patients with Heart Failure
Psotka, M. A., & Teerlink, J. R. (2013) · Heart Failure Clinics · doi:10.1016/j.hfc.2013.04.005 · Cited by 14 · see citing works
Who Signs Up for and Engages in a Peer Support Heart Failure Self-management Intervention
Mase, R., Halasyamani, L. K., Choi, H., & Heisler, M. (2014) · The Journal of Cardiovascular Nursing · doi:10.1097/jcn.0000000000000172 · Cited by 14 · see citing works
Vaduganathan, M., Harrington, R. A., Stone, G. W., Steg, P. G., Gibson, C. M., Hamm, C. W., Price, M. J., Prats, J., Deliargyris, E. N., Mahaffey, K. W., et al. (2016) · Circulation: Cardiovascular Interventions · doi:10.1161/circinterventions.116.003612 · Cited by 12 · see citing works
Self-citationIncentivizing Recruitment and Retention to Address Enrollment Challenges in Clinical Research
Dickert, N. W., Halpern, S. D., & Butler, J. (2013) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.113.000176 · Cited by 12 · see citing works
Self-citationTamargo, J. L., Rosano, G. M. C., Delpón, E., Ruilope, L. M., & Lopez-Sendon, J. L. (2016) · International Journal of Cardiology · doi:10.1016/j.ijcard.2016.11.124 · Cited by 11 · see citing works
Factors influencing the enrollment in randomized controlled trials in orthopedics
Lim, C. T., Roberts, H. J., Collins, J. E., Losina, E., & Katz, J. N. (2017) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2017.10.005 · Cited by 11 · see citing works
Are All Clinical Trial Sites Created Equal?
Bhatt, D. L., & Cavender, M. A. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.10.024 · Cited by 10 · see citing works
Koyanagi, R., Hagiwara, N., Yamaguchi, J., Kawada‐Watanabe, E., Haruta, S., Takagi, A., & Ogawa, H. (2013) · Journal of Cardiology · doi:10.1016/j.jjcc.2013.04.004 · Cited by 10 · see citing works
Vaduganathan, M., Samman‐Tahhan, A., Patel, R. B., Kelkar, A. A., Papadimitriou, L., Georgiopoulou, V. V., Greene, S. J., Kalogeropoulos, A. P., Peterson, E. D., Fonarow, G. C., et al. (2016) · International Journal of Cardiology · doi:10.1016/j.ijcard.2016.12.119 · Cited by 9 · see citing works
Self-citationCollins, S. P., Levy, P. D., Pang, P. S., & Gheorghiade, M. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.03.009 · Cited by 8 · see citing works
Self-citationDüngen, H., Petroni, R., Correale, M., Coiro, S., Monitillo, F., Triggiani, M., Leone, M., Antohi, E., Ishihara, S., Sarwar, C. M. S., et al. (2018) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000000669 · Cited by 8 · see citing works
Self-citationDiscontinuation and nonpublication of clinical trials in orthopaedic oncology
Singh, G., Wague, A., Arora, A., Rao, V., Ward, D., & Barry, J. J. (2024) · Journal of Orthopaedic Surgery and Research · doi:10.1186/s13018-024-04601-6 · Cited by 8 · see citing works
Acute heart failure in the emergency department: a follow-up study
Fabbri, A., Marchesini, G., Carbone, G., Cosentini, R., Ferrari, A., Chiesa, M., BERTINI, A., & Rea, F. (2015) · Internal and Emergency Medicine · doi:10.1007/s11739-015-1336-z · Cited by 7 · see citing works
Tahhan, A. S., Vaduganathan, M., Greene, S. J., Okafor, M. O., Kumar, S., & Butler, J. (2018) · Current Heart Failure Reports · doi:10.1007/s11897-018-0374-z · Cited by 7 · see citing works
Self-citationEnrollment in Heart Failure Clinical Trials: Insights Into Which Entry Criteria Exclude Patients
Krishnamoorthy, A., Tonks, R., Adams, P. A., Felker, G. M., Patel, C. B., & Mentz, R. J. (2015) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2015.04.008 · Cited by 6 · see citing works
Self-citationChavanon, M., Inkrot, S., Zelenak, C., Tahirović, E., Stanojević, D., Apostolovic, S. R., Šljivić, A., Ristić, A. D., Matić, D., Loncar, G., et al. (2017) · Clinical Research in Cardiology · doi:10.1007/s00392-017-1101-6 · Cited by 6 · see citing works
Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America
Ambrosy, A. P., Mentz, R. J., Krishnamoorthy, A., Greene, S. J., & Severance, H. W. (2015) · Heart Failure Clinics · doi:10.1016/j.hfc.2015.07.002 · Cited by 5 · see citing works
Self-citationKhan, M. S., Kalogeropoulos, A. P., & Butler, J. (2019) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2019.09.037 · Cited by 5 · see citing works
Self-citationRegional variation in patients and outcomes in the GLOBAL LEADERS trial
Gao, C., Takahashi, K., Garg, S., Hara, H., Wang, R., Kawashima, H., Ono, M., Montalescot, G., Haude, M., Slagboom, T., et al. (2020) · International Journal of Cardiology · doi:10.1016/j.ijcard.2020.09.039 · Cited by 5 · see citing works
REPORT-HF: The Unique Blend of Global Heart Failure Registry and Longitudinal Cohort Study
Greene, S. J., Fonarow, G. C., & Butler, J. (2015) · European Journal of Heart Failure · doi:10.1002/ejhf.264 · Cited by 4 · see citing works
Self-citationImportance of Internal Variability in Clinical Trials of Cardiovascular Disease
Reed, G. W., Parikh, P., & Nissen, S. E. (2021) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2021.06.020 · Cited by 3 · see citing works
Progress or lack of progress in hospitalized heart failure
Vaduganathan, M., Butler, J., Fonarow, G. C., & Gheorghiade, M. (2013) · Expert Review of Cardiovascular Therapy · doi:10.1586/14779072.2013.827465 · Cited by 3 · see citing works
Self-citationHospitalized Heart Failure in the United States
Greene, S. J., AlKhawam, L., Ambrosy, A. P., Vaduganathan, M., & Mentz, R. J. (2015) · Heart Failure Clinics · doi:10.1016/j.hfc.2015.07.003 · Cited by 3 · see citing works
Self-citationVaduganathan, M., Butler, J., Roessig, L., Fonarow, G. C., Greene, S. J., Metra, M., Cotter, G., Kupfer, S., Zalewski, A. A., Sato, N., et al. (2015) · Heart Failure Reviews · doi:10.1007/s10741-015-9485-8 · Cited by 3 · see citing works
Self-citationClassification of Patients Hospitalized for Heart Failure
Vaduganathan, M., Marti, C. N., Georgiopoulou, V. V., Kalogeropoulos, A. P., & Butler, J. (2013) · Heart Failure Clinics · doi:10.1016/j.hfc.2013.04.002 · Cited by 3 · see citing works
Self-citationAhmad, T., & Butler, J. (2015) · European Journal of Heart Failure · doi:10.1002/ejhf.296 · Cited by 3 · see citing works
Self-citationMetra, M., Davison, B. A., Gimpelewicz, C. R., Carubelli, V., Felker, G. M., Filippatos, G. S., Greenberg, B., Hua, T. A., Liu, Z. S.-J., Pang, P. S., et al. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2017.09.185 · Cited by 2 · see citing works
Lansang, E. Z., Horsburgh, D., Lee, Y. N., Sng, A., Moussalli, R., Wai, K., Anand, I. S., Zhang, S., Shimizu, W., Narasimhan, C., et al. (2014) · ASEAN heart journal · doi:10.7603/s40602-014-0015-z · Cited by 2 · see citing works
Site Selection and Performance in Clinical Trials
McMurray, J. J. V. (2016) · Circulation Heart Failure · doi:10.1161/circheartfailure.116.003490 · Cited by 2 · see citing works
Glasser, S. P. (2014) · Springer eBooks · doi:10.1007/978-3-319-05470-4_3 · Cited by 1 · see citing works
Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial
Arrigo, M., Davison, B. A., Edwards, C., Adamo, M., Ambrosy, A. P., Barros, M., Biegus, J., Čelutkienė, J., Čerlinskaitė‐Bajorė, K., Chioncel, O., et al. (2024) · American Heart Journal · doi:10.1016/j.ahj.2024.04.019 · Cited by 1 · see citing works
Self-citationRecruitment Practices in Multicenter Randomized Clinical Trials: Time for a Relook
Gaba, P., & Bhatt, D. L. (2021) · Journal of the American Heart Association · doi:10.1161/jaha.121.023673 · Cited by 1 · see citing works
Hospitalized Heart Failure in the United States Learned from Clinical Trial
Greene, S. J., AlKhawam, L., Ambrosy, A. P., Vaduganathan, M., & Mentz, R. J. (2015)
Self-citationRekha, G. N. (2017) · IEEE Technology & Engineering Management Conference (TEMSCON) · doi:10.1109/temscon.2017.7998391
Abdulai, R. M. (2017) · Digital Access to Scholarship at Harvard (DASH) (Harvard University)
Electronic health records-based research in Cardiology: The time has come for pragmatic trials
Seabra, D., Oliveira, A., & Gavina, C. (2025) · Revista Portuguesa de Cardiologia · doi:10.1016/j.repc.2024.12.007
- Authors
- Butler, J., Subacius, H., Vaduganathan, M., Fonarow, G. C., Ambrosy, A. P., Konstam, M. A., Maggioni, A., Mentz, R. J., Swedberg, K., Zannad, F., & Gheorghiade, M.
- Affiliations
- Emory University (US)
- Northwestern University (US)
- Harvard University (US)
- University of California, Los Angeles (US)
- Stanford University (US)
- Tufts University (US)
- Associazione Nazionale Medici Cardiologi Ospedalieri (IT)
- Duke University (US)
- University of Gothenburg (SE)
- Inserm (FR)
- Corresponding author
- Gheorghiade, Mihai
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2013-02
- Volume
- 61
- Issue
- 5
- Pages
- 571-579
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W133383503
- Cited by
- 60
- References
- 24
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2021: 3 · 2020: 1 · 2019: 2 · 2018: 5 · 2017: 6 · 2016: 6 · 2015: 13 · 2014: 10 · 2013: 9 · 2012: 1
- FWCI
- 6.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Cytokinetics
- Novartis
- Otsuka America
- Medtronic
- Servier
- Amgen
- AstraZeneca
- Gilead Sciences
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- acute heart failure, cardiovascular mortality, heart failure hospitalization, participant characteristics, ACE inhibitors, mineralocorticoid receptor antagonists, ejection fraction, comorbidities, trial outcomes
- MeSH terms
- Tolvaptan, Aged, Aged, 80 and over, Benzazepines, Clinical Protocols, Double-Blind Method, Europe, Europe, Eastern, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, North America, Prospective Studies, South America, Vasopressins, Survival Rate, Treatment Outcome, Patient Selection, Internationality
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
