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Time to move on from 'time-to-first': should all events be included in the analysis of clinical trials?

Anker, S. D., & McMurray, J. J. V. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs277 · Cited by 99 · see citing works

Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study

Mahaffey, K. W., Harrington, R. A., Akkerhuis, K. M., Kleiman, N. S., Berdan, L. G., Crenshaw, B. S., Tardiff, B. E., Granger, C. B., DeJong, I., Bhapkar, M. V., et al. (2001) · Trials · doi:10.1186/cvm-2-4-187 · Cited by 87 · see citing works

Day of Admission and Clinical Outcomes for Patients Hospitalized for Heart Failure

Fonarow, G. C., Abraham, W. T., Albert, N. M., Stough, W. G., Gheorghiade, M., Greenberg, B., O’Connor, C. M., Núñez, E., Yancy, C. W., & Young, J. B. (2008) · Circulation Heart Failure · doi:10.1161/circheartfailure.107.748376 · Cited by 78 · see citing works

Misreporting of myocardial infarction end points: Results of adjudication by a central clinical events committee in the PARAGON-B trial

Mahaffey, K. W., Roe, M. T., Dyke, C. K., Newby, L. K., Kleiman, N. S., Connolly, P., Berdan, L. G., Sparapani, R., Lee, K. L., Armstrong, P. W., et al. (2002) · American Heart Journal · doi:10.1067/mhj.2002.120145 · Cited by 78 · see citing works

A Global Rank End Point for Clinical Trials in Acute Heart Failure

Felker, G. M., & Maisel, A. S. (2010) · Circulation Heart Failure · doi:10.1161/circheartfailure.109.926030 · Cited by 76 · see citing works

Systematic adjudication of myocardial infarction end-points in an international clinical trial

Mahaffey, K. W., Harrington, R. A., Akkerhuis, K. M., et al. (2001) · Trials · doi:10.1186/cvm-2-4-180 · Cited by 75 · see citing works

Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials

Bakal, J. A., Westerhout, C. M., & Armstrong, P. W. (2012) · Statistical Methods in Medical Research · doi:10.1177/0962280211436004 · Cited by 70 · see citing works

A Comparison of the Effects of Carvedilol and Metoprolol on Well-Being, Morbidity, and Mortality (the “Patient Journey”) in Patients With Heart Failure

Cleland, J. G. F., Charlesworth, A., Lubsen, J. C., Swedberg, K. B., Remme, W. J., Erhardt, L., Lenarda, A. D., Michel Komajda, N., Metra, M., Torp-Pedersen, C. T., et al. (2006) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2005.11.069 · Cited by 68 · see citing works

Dyspnea as an end point in clinical trials of therapies for acute decompensated heart failure

Teerlink, J. R. (2003) · American Heart Journal · doi:10.1067/mhj.2003.151 · Cited by 68 · see citing works

A review of dyspnea in acute heart failure syndromes

West, R. L., Hernandez, A. F., O'Connor, C. M., Starling, R. C., & Califf, R. M. (2010) · American Heart Journal · doi:10.1016/j.ahj.2010.05.020 · Cited by 67 · see citing works

Real World Evaluation of Dual-Zone ICD and CRT-D Programming Compared to Single-Zone Programming: The ALTITUDE REDUCES Study

Gilliam, F. R., Hayes, D. L., BOEHMER, J. P., DAY, J., Heidenreich, P. A., Seth, M., Jones, P. W., Steín, K. M., & Saxon, L. A. (2011) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2011.02086.x · Cited by 66 · see citing works

International Variations in the Clinical, Diagnostic, and Treatment Characteristics of Emergency Department Patients with Acute Heart Failure Syndromes

Collins, 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

The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee?s final decision on end-points

Näslund, U. (1999) · European Heart Journal · doi:10.1053/euhj.1998.1351 · Cited by 57 · see citing works

Current use of pacemakers, implantable cardioverter defibrillators, and resynchronization devices: data from the registry of the European Heart Rhythm Association

Ector, H., & VARDAS, P. E. (2007) · European Heart Journal Supplements · doi:10.1093/eurheartj/sum062 · Cited by 56 · see citing works

Refining clinical trial composite outcomes: An application to the Assessment of the Safety and Efficacy of a New Thrombolytic–3 (ASSENT-3) trial

Armstrong, P. W., Westerhout, C. M., de Werf, F. V., Califf, R. M., Welsh, R. C., Wilcox, R. G., & Bakal, J. A. (2011) · American Heart Journal · doi:10.1016/j.ahj.2010.12.026 · Cited by 55 · see citing works

Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition

Zannad, F. M., Stough, W. G., Pitt, B., Cleland, J. G. F., Adams, K. F., Geller, N. L., Torp-Pedersen, C. T., Kirwan, B., & Folláth, F. (2008) · European Heart Journal · doi:10.1093/eurheartj/ehm603 · Cited by 52 · see citing works

Physician-Determined Worsening Heart Failure: A Novel Definition for Early Worsening Heart Failure in Patients Hospitalized for Acute Heart Failure – Association with Signs and Symptoms, Hospitalization Duration, and 60-Day Outcomes

Cotter, G., Metra, M., Davison, B. A., Dittrich, H. C., Massie, B. M., Ponikowski, P. P., Bloomfield, D. M., & O’Connor, C. M. (2009) · Cardiology · doi:10.1159/000249280 · Cited by 49 · see citing works

Quality of life monitoring in ambulatory heart failure patients: temporal changes and prognostic value

Lupón, J., Gastelurrutia, P., de Antonio, M., et al. (2012) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfs133 · Cited by 48 · see citing works

How to Assess New Treatments for the Management of Heart Failure: Composite Scoring Systems to Assess the Patients’ Clinical Journey

Cleland, J. G. F. (2002) · European Journal of Heart Failure · doi:10.1016/s1388-9842(02)00039-9 · Cited by 47 · see citing works

Elevated Urinary Neutrophil Gelatinase-Associated Lipocalcin after Acute Heart Failure Treatment is Associated with Worsening Renal Function and Adverse Events

Collins, S. P., Hart, K. W., Lindsell, C. J., et al. (2012) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfs087 · Cited by 45 · see citing works

Predictors of Early Dyspnoea Relief in Acute Heart Failure and the Association with 30-Day Outcomes: Findings from ASCEND-HF

Mentz, R. J., Hernandez, A. F., Stebbins, A., Ezekowitz, J. A., Felker, G. M., Heizer, G., Atar, D., Teerlink, J. R., Califf, R. M., Massie, B. M., et al. (2012) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfs188 · Cited by 45 · see citing works

A Global Ranking Approach to End Points in Trials of Mechanical Circulatory Support Devices

Felker, G. M., Anstrom, K. J., & Rogers, J. G. (2008) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2008.01.009 · Cited by 45 · see citing works

Self-Assessed Symptoms in Chronic Heart Failure — Important Information for Clinical Management

Ekman, I., Kjörk, E., & Andersson, B. (2006) · European Journal of Heart Failure · doi:10.1016/j.ejheart.2006.10.020 · Cited by 43 · see citing works

Clinical Trials in Acute Heart Failure: Simpler Solutions to Complex Problems. Consensus Document Arising from a European Society of Cardiology Cardiovascular Round-Table Think Tank on Acute Heart Failure, 12 May 2009

McDonagh, T. A., Michel Komajda, N., Maggioni, A. P., Zannad, F. M., Gheorghiade, M., Metra, M., & Dargie, H. J. (2011) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfr126 · Cited by 34 · see citing works

JACC: Cardiovascular Interventions: The End of the Beginning

D, E. B. M. (2008) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2007.12.003 · Cited by 34 · see citing works

Comparing classifications of death in the Mode Selection Trial: Agreement and disagreement among site investigators and a clinical events committee

Petersen, J. L., Haque, G., Hellkamp, A. S., Flaker, G. C., Estes, N. A. M., Marchlinski, F. E., McAnulty, J. H., Greenspon, A. J., Marinchak, R. A., Lee, K. L., et al. (2006) · Contemporary Clinical Trials · doi:10.1016/j.cct.2006.02.002 · Cited by 34 · see citing works

Determination of hospitalization type by investigator case report form or adjudication committee in a large heart failure clinical trial (β-Blocker Evaluation of Survival Trial [BEST])

Carson, P., Fiuzat, M., O'Connor, C., Anand, I., Plehn, J., Lindenfeld, J. A., Silver, M., White, M., Miller, A., Davis, G., et al. (2010) · American Heart Journal · doi:10.1016/j.ahj.2010.07.004 · Cited by 31 · see citing works

Unconventional End Points in Cardiovascular Clinical Trials: Should We Be Moving Away From Morbidity and Mortality?

Cohn, J. N., Cleland, J. G. F., Lubsen, J. C., BORER, J. S., Steg, P. G., Perelman, M., & Zannad, F. M. (2008) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2008.10.029 · Cited by 31 · see citing works

Implantable Cardioverter Defibrillator Electrogram Adjudication for Device Registries: Methodology and Observations from ALTITUDE

Powell, B. D., Cha, Y., Asirvatham, S. J., Cesario, D. A., Cao, M. K., Jones, P. W., Seth, M., Saxon, L. A., & Gilliam, F. R. (2011) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2011.03093.x · Cited by 28 · see citing works

Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements?

Zannad, F. M., Stough, W. G., Pocock, S., Sleight, P., Cushman, W. C., Cleland, J. G. F., McMurray, J. J. V., Lonn, E., Geller, N. L., Wedel, H., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehr437 · Cited by 18 · see citing works

Influence of Proteinuria on Cardiovascular Risk and Response to Angiotensin-Converting Enzyme Inhibition After Myocardial Infarction

Jose, P. O., Tomson, C., Skali, H., et al. (2006) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2006.01.047 · Cited by 16 · see citing works

From batting average to wins above replacement to composite end points—refining clinical research using baseball statistical methods

Anstrom, K. J., & Eisenstein, E. L. (2011) · American Heart Journal · doi:10.1016/j.ahj.2011.01.023 · Cited by 12 · see citing works

Antithrombotic outcome trials in acute coronary syndromes: seeking the optimal balance between safety and efficacy†

Verheugt, F. W. A., Clemmensen, P., Mehran, R., et al. (2013) · European Heart Journal · doi:10.1093/eurheartj/eht013 · Cited by 11 · see citing works

Analysing recurrent hospitalizations in heart failure: A review of statistical methodology, with application to CHARM-preserved

Rogers, J., Pocock, S., McMurray, J. J. V., et al. (2014) · Research Bank (Australian Catholic University) · Cited by 11 · see citing works

Abstract 15606: Clevidipine Improves Dyspnea in Emergency Department Acute Heart Failure: A Randomized, Open Label Study

Peacock, W. F., Chandra, A. B., Collins, S. P., Fonarow, G. C., Garrison, N. A., & Mebazaa, A. (2012) · Circulation · Cited by 8 · see citing works

Testosterone Therapy in Women With Heart Failure

Armstrong, P. W., & Ezekowitz, J. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.03.091 · Cited by 6 · see citing works

Measurement of end points in heart failure trials: jousting at windmills?

Hauptman, P. J. (2004) · PubMed · Cited by 4 · see citing works

DO COUNTRIES OR HOSPITALS WITH LONGER STAYS HAVE LOWER READMISSION RATES? FINDINGS FROM THE ASCEND-HF TRIAL

Eapen, Z. J., Reed, S. D., Li, Y., et al. (2012) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(12)61030-4 · Cited by 3 · see citing works

Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalisations

Rogers, J. K., McMurray, J. J. V., Pocock, S., et al. (n.d.) · University of Groningen research database (University of Groningen / Centre for Information Technology) · Cited by 3 · see citing works

Anti-Inflammatory Therapy With Canakinumab for the Prevention of Hospitalization for Heart Failure

Everett, B. M., Cornel, J. H., Lainscak, M., Anker, S. D., Abbate, A., Thuren, T., Libby, P., Glynn, R. J., & Ridker, P. M. (2019) · Circulation · doi:10.1161/circulationaha.118.038010 · Cited by 658 · see citing works

The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials

Anker, S. D., Agewall, S., Borggrefe, M., Calvert, M., Jaime Caro, J., Cowie, M. R., Ford, I., Paty, J. A., Riley, J. P., Swedberg, K., et al. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu205 · Cited by 362 · see citing works

Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting: Evidence From the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM-HF)

Okumura, N., Jhund, P. S., Gong, J., Lefkowitz, M. P., Rizkala, A. R., Rouleau, J. L., Shi, V. C., Swedberg, K., Zile, M. R., Solomon, S. D., et al. (2016) · Circulation · doi:10.1161/circulationaha.115.020729 · Cited by 186 · see citing works

Renal Denervation in Heart Failure with Preserved Ejection Fraction (RDT-PEF): A Randomized Controlled Trial

Patel, H. C., Rosen, S. D., Hayward, C., Vassiliou, V., Smith, G. C., Wage, R. R., Bailey, J., Rajani, R., Lindsay, A. C., Pennell, D. J., et al. (2016) · European Journal of Heart Failure · doi:10.1002/ejhf.502 · Cited by 92 · see citing works

Prioritizing symptom management in the treatment of chronic heart failure

Koshy, A. O., Gallivan, E. R., McGinlay, M., Straw, S., Drozd, M., Toms, A. G., Gierula, J., Cubbon, R. M., Kearney, M. T., & Witte, K. K. (2020) · ESC Heart Failure · doi:10.1002/ehf2.12875 · Cited by 66 · see citing works

Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials

McMurray, J. J. V., Docherty, K. F., de Boer, R. A., Hammarstedt, A., Kitzman, D. W., Kosiborod, M. N., Maria Langkilde, A., Reicher, B., Senni, M., Shah, S. J., et al. (2024) · Circulation · doi:10.1161/circulationaha.123.065061 · Cited by 60 · see citing works

Clinical Trial Design, Endpoints, and Regulatory Requirements

Rosano, G. M. C. (2016) · Handbook of Experimental Pharmacology · doi:10.1007/164_2016_75 · Cited by 7 · see citing works

Clinical and prognostic implications of heart failure hospitalization in patients with advanced heart failure

Pagnesi, M., Sammartino, A. M., Chiarito, M., Stolfo, D., Baldetti, L., Adamo, M., Maggi, G., Inciardi, R. M., Tomasoni, D., Loiacono, F., et al. (2023) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000001581 · Cited by 10 · see citing works

Consistency ensured test strategies for supportive evidence of treatment efficacy in noninferiority clinical trials

Huque, M. F., Valappil, T., & Alosh, M. (2017) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2017.1399899

Selecting the primary endpoint in a randomized clinical trial: The ARE method

Plana‐Ripoll, O., & Melis, G. G. (2015) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2015.1094808 · Cited by 3 · see citing works

Clinical Endpoint: Substitute for Prediction of Clinical Benefit

Kumar, R. S., & Krishna, A. (2019) · Journal of Drug Delivery and Therapeutics · doi:10.22270/jddt.v9i4-s.3367

A Consistency-Adjusted Strategy for Accommodating an Underpowered Primary Endpoint

Huque, M. F., & Alosh, M. (2011) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2010.513464 · Cited by 13 · see citing works