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Rationale, design, implementation, and baseline characteristics of patients in the dig trial: A large, simple, long-term trial to evaluate the effect of digitalis on mortality in heart failure
Authors :
Abernathy, GT Abrams, J Akhtar, S Albitar, I Amidi, M Anand, IS Arnold, JMO Ashton, T Aubrey, B Auger, P Babb, J Baigrie, R Baird, MG Baitz, T Barber, NC Barbour, DJ Barr, DM Basu, AK Baughman, KL Beckham, V BekheitSaad, S Berkson, DM Bertoglio, M Bessoudo, R Beaudoin, J Bhaskar, G Binder, A Bloomfield, D Bodine, K Boehmer, JP Borgersen, K Borts, D Bouchard, G Bourassa, MG Boutros, G Bozek, B Brisbin, D Brophy, J Brossoit, R Brown, E Brown, J Bruinsma, N Burton, G Cameron, A Campbell, R Campeau, J Campos, EE Cardello, FP Carter, RP Chan, YK Charles, FR Chaudhry, MA Chiaramida, A Chiaramida, S Chohan, A Christie, LG Clemson, BS Collin, R Cook, TH Copen, DL Cossett, J Costantino, T Crawford, MH Croke, RP Crowell, R DAmours, G Dagenais, GR Danisa, K Davidson, S Davies, ML Davies, R Davies, RA DeLarochelliere, R DeLeon, AC Delage, F Denes, P Dennish, GW Denny, DM DeVilla, MA DeYoung, JP Dhurandhar, RW DibnerDunlap, M Dodek, A Doherty, JE Dominguez, J Dubbin, J Dufton, J Effron, MB ElSherif, N Eladasari, B Fly, D Ericson, K Fahrenholtz, D Fast, A Fell, DA Fishman, S Fitchett, D Fleg, JL Flint, E Folger, JS Folkins, D Forker, AD Fowles, RE Fraker, TD Francis, G Frerking, TR Friesinger, GC Fulop, JC Gagnon, J Gamble, L Ganjavi, F Garrou, BW Gervais, PB Gheorghiade, M Gilbert, L Gillie, E Glatter, TR Godley, ML Goeres, M Goldberger, MH Gollapudi, A Goode, JE Goodman, LS Gordon, R Gossard, D Gosselin, G Goulet, C Grant, C Graettinger, WF Greene, JG Greenwood, PV Gregoratos, G Gregory, JJ Groden, DL Grover, J Gudapati, R Guess, MA Gupta, SC Habib, N Hack, I Hamilton, WP Hankey, TL Hanna, M Harper, D Harris, DE Hassapoyannes, CA Hatheway, RJ Heinsimer, J Pequignot, MH Heiselman, DE Hess, AR Hickner, J Hickey, JE Higgins, T Higginson, L Hill, L Hobbs, RE Honos, G Horner, BA Horwitz, L Hsieh, A Hsueh, JT Hubbard, J Hughes, DF Hui, W Imrie, JR Jacobs, MH Jarmukli, N Johnson, TH Johnstone, D Jutila, CK Kadri, N Kahl, FR Kaimal, PK Karnegis, J Kay, R Kelly, KJ Kenefick, G Kennelly, BM Kent, E Khan, AH Khanijo, V Khouri, M Kinloch, D Kirlin, PC Kiwan, GS Kline, MD Kohn, RM Koilpillai, C Kornder, JM Kouz, S Kumar, VA Kumar, U Kuntz, A Kuritzky, RA Kuruvilla, G Kwok, KK Lader, E Laforest, M LaForge, D Lalonde, G Lalonde, L Lang, RM Latour, Y Lawal, O LeBlanc, MH Lee, AB Lee, RW Legault, C Lemay, M Lenis, JHF Lepage, S Letarte, P Levesque, C LevinoffRoth, SN Lewis, BK Lipshutz, H Loungani, RR Lowery, ML Lubell, DL Lucariello, R LugoRodriguez, JE Lui, C Lutterodt, AT Lutz, L Machel, T Macina, G MacLellan, K Magnan, O Mansuri, M Manyari, DE Mallis, GI Marr, D Mast, DJ Mathew, J McBarron, FD McIntyre, KM McLean, RW McMahon, DP Mercier, M Methe, M Miller, AB Minkowitz, J Milton, JR Mizgala, HF Mohanty, PK Mohiuddin, S Montero, A Mookherjee, S Morris, A Morris, L Morrison, J Moten, M Nafziger, A Nair, PH Nawaz, S Neiman, JC Nutting, P NguyenPho, HT OBrien, TK OKelly, RL OReilly, MV Okerson, D Patel, G Pande, PN Papa, LA Patrick, L Payne, RM Perry, G Philbin, EF Pierpont, G Pitt, WA Poirier, C Pollak, EM Popio, K Poulin, JF Probst, PA Pruneau, G Pu, C Puram, BS Putatunda, B Quinn, B Rabkin, SW Racine, N Raco, DL Radant, L Radford, MJ Radwany, S Rajachar, M Ramanathan, KB Rashkow, A Rausch, DC Read, L Reddy, KR Reid, R Rich, MW Ricci, AJ Richman, HG Riley, A Rim, DA Rinne, C Roberge, G Roberts, DK Robinson, V Rodeheffer, RT Rosenstein, R Roth, DL Rothbart, R Rouleau, JL Ruble, P Sacco, J Safford, RE Salmon, D Sahay, BM Sarma, RJ Sayeed, MAR Schick, EC Schroeder, GS Seifert, M Senaratne, MPJ Sestier, F Shah, A Shanes, JG Sheesley, K Silverman, A Shiva, T Shrestha, DD Silver, MA Silverberg, L Simard, L Singh, BN Small, RS Smith, MR Smith, S Sochowski, RA Southern, RF Sridharan, MR StHilaire, R Stein, M Stewart, JW Stillabower, ME Sullivan, BHM Sturrock, WA Sussex, BA Swan, J Swenson, L Talbot, P Talibi, T Tamilia, M Tan, A Tanser, PH Tarry, L Teo, KK Thadani, U Thagirisa, S Thompson, B Thornton, R Timmis, GC Tobin, M Tommaso, C Toren, M Tsuyuki, R Turek, M Utley, K Vanderbush, EJ VanVoorhees, L Ventura, H Vertes, G Vizel, S Wagner, KR Wagner, S Weeks, A Weingert, ME Weinstein, C Weiss, MM Weiss, R Wickemeyer, W Wielgoz, A Willens, HJ Williams, WL Wong, D Yarows, SA Yao, L Shalev, Y Young, JB Yousefian, M Zajac, EJ Zatuchni, J Ziperman, DB Zoble, RG Zoneraich, S Gorlin, R Sleight, P Cohn, JN Collins, R Deykin, D Hennekens, C Kjekshus, J Smith, TW Tognoni, G Collins, JF Williford, WO Fye, C Sather, R Jolly, MK Held, CP Verter, J Yusuf, S Egan, D Garg, R Johnstone, DE Montague, T Bristow, D Engelhardt, HT Gent, M Hood, WB Jones, S Meier, P Pitt, B Waters, D Baker, A Barnhill, S Carew, B Hagar, S Liuni, C Martin, S Miles, R Arthur, MM Feldbush, MW Highfield, DA Hobbins, TE Kurz, R Leviton, SP Libonati, JP Moore, M Perez, E Mills, P Geller, N Hunsberger, S Gold, J Huang, PC Burns, A Caleb, H Cline, DR Harris, S Hockenbrock, R Horney, RA Jadwin, LM King, J Sexton, P Spence, ME Chacon, F Gagne, W Maple, S Martinez, G
Source :
ResearcherID
Publication Year :
1996
Publisher :
Elsevier BV, 1996.
Abstract
This article provides a detailed overview of the rationale for key aspects of the protocol of the Digitalis Investigation Group (DIG) trial. It also highlights unusual aspects of the study implementation and the baseline characteristics. The DIG trial is a large, simple, international placebo-controlled trial whose primary objective is to determine the effect of digoxin on all cause mortality in patients with clinical heart failure who are in sinus rhythm and whose ejection fraction isor = 0.45. An ancillary study examines the effect in those with an ejection fraction0.45. Key aspects of the trial include the simplicity of the design, broad eligibility criteria, essential data collection, and inclusion of various types of centers. A total of 302 centers in the United States and Canada enrolled 7788 patients between February 1991 and September 1993. Follow-up continued until December 1995 with the results available in Spring 1996.
Details
ISSN :
01972456
Volume :
17
Database :
OpenAIRE
Journal :
Controlled Clinical Trials
Accession number :
edsair.doi.dedup.....a53020033d9d8dfff55d8b37c53b6c8f