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The effect of digoxin on mortality and morbidity in patients with heart failure

Perry, G; Brown, E; Thornton, R; Shiva, T; Hubbard, J; Reddy, KR; Doherty, JE; Cardello, FP; Fast, A; Radford, MJ; Folger, JS; Bhaskar, G; Zoble, RG; Sridharan, V; Sridharan, MR; Loungani, RR; Gheorghiade, M; Hsieh, A; Tommaso, C; Mansuri, M; Guess, MA; Akhtar, S; Wagner, S; Hagan, K; McIntyre, KM; Ruble, P; Moten, M; Riley, A; Pierpont, G; Anand, I; Patel, G; Puram, BS; Eladasari, BR; Karnegis, J; Gillie, E; Crawford, MH; Graettinger, WF; Shah, A; Sacco, J; Chaudhry, MA; Dolen, D; ElSherif, N; BekheitSaad, S; Campos, EE; Greene, JG; Khanijo, V; Kumar, U; Mallis, GI; Mookherjee, S; DibnerDunlap, M; Gupta, SC; Danisa, K; Thadani, U; Tan, A; Rajachar, M; Amidi, M; OReilly, MV; Hassapoyannes, CA; Davies, ML; Kumar, VA; Okerson, D; Ramanathan, KB; Putatunda, B; Gollapudi, A; Montero, A; Mohanty, PK; Lui, C; Thagirisa, S; Lee, RW; Glatter, TR; Bodine, K; Roberts, D; Bertoglio, M; Dennish, GW; Sarma, RJ; Gregoratos, G; Rausch, DC; Pitt, WA; Kennelly, BM; Fahrenholtz, D; Gordon, R; Horwitz, L; Rothbart, R; Nutting, P; Lutz, L; Copen, DL; Rashkow, A; Babb, J; VanVoorhees, L; Silverman, A; Stillabower, ME; Miller, AB; NguyenPho, HT; Safford, RE; Fishman, S; Neiman, JC; Stein, M; Dominguez, JC; Abernathy, GT; Nair, PH; Goodman, LS; Cook, TH; Wickemeyer, WJ; Berkson, DM; Mathew, J; Richman, HG; Lubell, DL; Lang, R; Zajac, EJ; Rosenstein, R; Silver, MA; Shanes, JG; Kelly, KJ; Pequignot, MH; Campbell, R; Kirlin, PC; Ziperman, DB; Denny, DM; Gamble, L; Weiss, M; Kaimal, PK; Dhurandhar, RW; Ventura, H; Godley, ML; Pu, C; Schick, EC; Barbour, DJ; Salmon, D; Goldstein, M; Effron, MB; Fleg, JL; Baughman, KL; Weiss, R; Ericson, K; Sturrock, WA; Heinsimer, J; Timmis, GC; Smith, S; Shrestha, DD; Duvernoy, WFC; Hickner, J; Lewis, BK; OBrien, TK; Yarows, SA; Willens, HJ; Mast, DJ; Johnson, TH; Rodeheffer, RJ; Siefert, M; Swenson, L; Denes, P; Gudapati, R; Charles, FR; Rich, MW; Beckham, V; Hamilton, WP; Abele, PB; Harper, DM; OKelly, RL; Forker, AD; Kahl, FR; Garrou, BW; Klang, TE; Popio, K; Mohiuddin, S; Pollak, EM; Chiaramida, A; Gregory, JJ; Papa, LA; Abrams, J; Ung, S; Jutila, CK; Croke, RP; Chiaramida, S; Lucariello, R; Rim, DA; Goldberger, MH; Kohn, RM; Graham, S; Philbin, EF; Sheesley, K; Nafziger, A; Macina, G; Hsueh, JT; Zoneraich, S; Binder, A; Weinstein, C; Morrison, J; Cameron, A; Vanderbush, E; Brown, J; Pande, PN; Lader, E; Kay, R; Bloomfield, D; Costantino, T; Heiselman, DE; Radwany, S; Smith, MR; Hobbs, RE; Fraker, TD; Frerking, TR; DeLeon, AC; Christie, LG; Toren, M; Grover, J; McBarron, FD; Harris, DE; McLean, RW; Morris, L; Zatuchni, J; Boehmer, JP; Clemson, BS; Lipshutz, H; Small, RS; Ufret, R; LugoRodriquez, JE; Khan, AH; Yousefian, M; Friesinger, GC; Ely, D; Farmer, JA; Young, JB; Payne, RM; Fowles, RE; Lee, AB; Shalev, Y; AlBitar, I; Schroeder, GS; Radant, L; Hankey, TL; Rezkalla, S; Groden, DL; Teo, KK; Humen, DP; Wong, D; Greenwood, PV; Talibi, T; Hui, W; Klinke, WP; Senaratne, MPJ; Goeres, M; Hughes, DF; Sayeed, MAR; Roth, DL; Belenkie, I; Manyari, DE; Borgersen, K; Read, L; Kinloch, D; Reid, R; Barber, NC; Horner, BA; Kenefick, G; Kuritzky, RA; Imrie, JR; Wagner, KR; Rabkin, SW; Mizgala, HF; Tarry, L; Dodek, A; Kornder, JM; Ashton, T; Barr, D; Dufton, J; Sweeny, R; Morris, A; Bessoudo, R; Marr, D; Milton, JR; Thompson, B; Robinson, V; Sussex, BA; Tobin, M; McMahon, DP; Folkins, D; Crowell, R; Lalonde, LD; Koilpillai, C; Hatheway, RJ; OReilly, MG; Machel, T; Hack, I; Stewart, JW; Tanser, PH; Sullivan, B; Hagar, S; Quinn, B; Davies, RA; Baird, MG; Williams, WL; LeMay, M; Higginson, L; Turek, M; Sochowski, RA; Weeks, A; Jacobs, MH; Baigrie, R; DeVilla, MA; Vertes, G; Bozek, B; Goode, JE; Ricci, AJ; Swan, J; Fell, DA; LevinoffRoth, SN; Arnold, JMO; Patrick, L; Southern, RF; Rinne, C; Brisbin, D; DeYoung, JP; Baitz, T; Vizel, S; Minkowitz, J; Letarte, P; Chan, YK; Kwok, KK; Nawaz, S; Ganjavi, F; Yao, L; Misterski, J; Raco, DL; Hess, AR; Kuruvilla, G; Silverberg, L; Borts, D; Fulop, JC; Weingert, ME; Carter, RP; Sahay, BM; Hickey, JE; Lalonde, G; Gosselin, G; Bourassa, MG; Goulet, C; Joyal, M; Methe, M; Honos, G; Fitchett, D; Serpa, A; Sestier, F; Roberge, G; Latour, Y; Rondeau, C; Gossard, D; Lenis, JHF; Brossoit, R; Simard, L; Delage, F; Auger, P; Saulnier, D; Talbot, P; Beaudoin, J; Campeau, J; Pruneau, G; Tamilia, M; Boutros, G; Comeau, B; Starra, R; StHilaire, R; Veilleux, J; Mercier, M; Poulin, JF; Maclellan, K; Lepage, S; Rouleau, JL; Bruinsma, N; Levesque, C; DeLarochelliere, R; LeBlanc, M; Kouz, S; Kiwan, GS; Laforest, M; Brooks, J; Bouchard, G; Gervais, PB; Brophy, J; Gagnon, J; Habib, N; Basu, AK; Lutterodt, AT; Khouri, M; Gorlin, R; Egan, D; Garg, R; Yusuf, S; Montague, T; Smith, TW; Cohn, JN; Dagenais, GR; Davies, R; Johnstone, DE; Fye, C; Sather, MR; Deykin, D; Francis, G; Collins, JF; Williford, WO; Singh, BN
Background The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial. We studied the effect of digoxin on mortality and hospitalization in a randomized, double-blind clinical trial. Methods In the main trial, patients with left ventricular ejection fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and angiotensin-converting-enzyme inhibitors (median dose of digoxin, 0.25 mg per day; average follow-up, 37 months). In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. Results In the main trial, mortality was unaffected. There were 1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1 percent) with placebo (risk ratio when digoxin was compared with placebo, 0.99; 95 percent confidence interval, 0.91 to 1.07; P = 0.80). In the digoxin group, there was a trend toward a decrease in the risk of death attributed to worsening heart failure (risk ratio, 0.88; 95 percent confidence interval, 0.77 to 1.01; P = 0.06). There were 6 percent fewer hospitalizations overall in that group than in the placebo group, and fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval, 0.66 to 0.79; P < 0.001). In the ancillary trial, the findings regarding the primary combined outcome of death or hospitalization due to worsening heart failure were consistent with the results of the main trial. Conclusions Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure. These findings define more precisely the role of digoxin in the management of chronic heart failure. (C) 1997, Massachusetts Medical Society. $$:
ISI:A1997WJ24000001
ISSN: 0028-4793
CID: 108143

Randomised double-blind trial of fixed low-dose warfarin with aspirin after myocardial infarction

Fuster V; Califf RM; Chesebro JH; Cohen M; Comp PC; Gheorghiade M; Hall J; Halperin J; Khan S; Kopecky S; Langer A; Molk B; Moss A; OConnor CM; OGara PT; Raskob E; Sutton J; Braunwald E; Bell WR; Furberg C; Rapaport E; DeMets D; Goldstein S; Richardson D; Hillis D; Bonow R; Kistler JP; Mohr JP; Sherman D; Fisher M; Feyzi J; Cook T; Califf RM; Harrington RA; Berkowitz SD; Jett L; Berdan L; McDougal M; Friedman E; Daniel J; Roncskevitz E; Hwang S; Crowell D; Paganini M; Andahl L; OConnor C; Lucas K; Collins GJ; Mark RJ; Siegel RM; Koehnemann G; Greer S; Schweitzer AC; Lawrence JE; Allen SM; Wiseman AH; Warwick DJ; Bennett WT; Simmons K; Sheikh KH; Hengerer T; Campbell PT; Patterson JT; Bates M; Mathews A; Roark SF; Marquis N; Goldner DB; Brown G; Parker JP; Wells CB; McGrew FA; Hamilton B; Carney RJ; Crispin S; Cummins FE; Nonnweiler JM; Collins GV; Hathaway J; Conn E; McWilliams C; Geroge JM; Roncevich T; Reeves BR; Dinsmore N; Bender R; DeRosa K; OConnor CM; Hoffman S; Wertheimer J; Turner S; Crandall CW; Higgins DL; Berger BC; Palazzo D; Fontanet H; Ford E; Chu AA; Pierson M; Seaworth JF; Jensen J; Hoche JP; Ford EA; Goodfield P; Sprowls H; Schmidt PJ; Ness C; ODonnell G; McNamee S; Koren MJ; Baker J; Hassel CD; Hartley D; Unks M; Rodgers K; Muhlestein JB; Allen A; Sacchi TJ; Major A; Kmonicek JM; Shane JW; Goulah RD; Harner R; Bannon PJ; Heyl AE; Wall TC; Milks S; Ramo BW; Heimgartner K; Vranian RB; Louder DR; Stack RK; Jackson LL; Berman EJ; Hawkins D; Aycock GR; Wilcox T; West SR; Fowler P; Alagona P; Moore A; Hines J; Minor JR; Kereiakes DJ; Martin LH; Frid DJ; Homan JA; Burks JM; Kirby JC; Puma J; Jones L; Schneider RM; Lyttle B; Talley JD; Ashcraft S; Joseph A; CorumHartly J; McNeer JF; Laden DL; Belkin RN; Williamson J; Langer A; Hill C; Buttoo K; Kachra A; Langer G; Kavannaugh L; Shrives DM; Strauss H; Anderson P; Kwok K; Kern C; Cheung MT; Nawrocki H; Darcel IC; Ali N; Campbell D; Sluzar V; Hink H; Lam J; Marquis J; Parker JD; Wilson J; James R; Nolf B; Zawadowski A; Bhargava R; Gupta M; Sevitt B; Fitzsimons J; Burke BR; Chomyc R; Singh N; Bozek B; Roth SL; Smith J; Fell DA; Willoughy L; Ranganathan N; Nawrocki H; Langer A; Hill C; Morgan C; Balleza L; Sasson Z; Nolf B; LenkeiKerwin S; Wilson J; McAlister NH; Karhra N; Gangbar E; Willoughby L; Hess A; Gaudet M; Bhesania T; Burge D; OGara P; Haggan C; Gibson M; Slater A; Stone PH; Clemente C; Polansky BJ; Clements PJ; Schael F; McGough E; Daum RM; Carey G; Gillam LD; Hall DJ; Venditti FJ; Woodhead G; Birkhead RG; McConnell D; Jang IK; Haggan C; Sadaniantz A; Staples E; Weinshel AJ; Weinshel G; Cohen M; Sherwood J; Palabrica T; Brown AM; Hack TC; Pavao F; McKendall FR; Wheeler JL; Gaughan C; Medici SE; Losordo DW; Hallette N; Waldman H; Criasia M; Battle R; Rowen M; Klein ME; Hankin B; Radford MJ; Kearney L; Becker RC; Ball SP; Sharma GVRK; Lapsley DP; Watrous BG; Stanton A; Kopecky S; Holland A; Shelhamer L; Gudmonson K; Basu HN; Brickman D; Ramee SR; Landry KJ; Heltne CE; Bergal LA; Lyons RM; Bussey HI; Asinger R; Fifield JH; Bruns DL; Gadient L; Kincaid D; Berg S; Storvick E; Westphal D; Rezkalla SH; White E; Safford RE; Doucette K; Cookman JJ; Fangman L; Anderson BJ; Swan M; Kouba C; Theige T; Vacek JL; Nolte B; Hurley DV; Kaskie K; Gard JR; Harre SJ; Solberg L; Miller K; Miller RR; Rickards J; Yawn RA; Kurland M; Haugland JM; Slivken R; Hession WT; Strum S; Stowers SA; Abuan T; DeWood MA; Reinhardt S; Kopecky SL; Richardson D; Isele R; Block C; Swenson LJ; Vittum KA; Weeks G; Brennan M; Chapman D; ThomMorgan J; Chelliah N; Carter D; Friedman B; Haffey K; Webel R; Rood M; Andrews TC; July ME; Edin AE; Hester TS; Sutton J; McCollough T; Schulman D; Deloplaine K; Besley D; Dunn S; Richards F; Shipman D; Josephson RA; Jasso D; Fleischer L; Lofrano S; Spriggs D; Wahl S; Font VE; Trottier M; Sutton J; DeLuca SA; Schwarz EF; Beckham T; Mickolich JR; Snyder M; Langholz D; Johnson E; Beaver BB; Tedrick R; Boyd JJ; Probst P; Bear PA; Craig MB; Blumenthal RS; Carnes T; Villa AE; Atkins F; Storer WQ; Payne MA; ODonnell MJ; Prochnow L; Yakubov S; Noethen A; Gonzalez M; Jopperi E; Joyce D; Mishak S; Reen BM; Whisnant DR; Gacioch GM; Chiodo V; Effron MB; Utley K; Frank S; Dankoski C; Krauthamer D; Welcom GT; Aguirre FV; Stonner T; Cannon L; Harris M; Brown DL; MoeHufford K; Hattemer CR; Howard W; Gilmore PS; Wofford R; Bates ER; Alexandris C; McClure JM; Dinninger J; Molk B; Danhour G; Pacheco JP; Longo JA; Molk BL; Bickett K; Baum RS; Jenkins R; Brockington L; Harding C; Luckasen GJ; Rayder K; Ptasnik MJ; Harding C; Brachfeld CA; Vincze T; Cadigan RA; Wubbena BA; Smith BR; ONeill D; Pachelo GM; Godfrey CC; Fecik C; Larson D; Rayder K; Backup LD; Drake Z; Miklin JS; Aris G; Schwartz DJ; Stark S; Smith S; Eastburn T; Marsh R; Lorenz S; Thompson R; Kleinman J; Aris G; Breckinridge JC; Dauber IM; Bell W; VanBenthuysen K; Prevedel J; Fecik C; Stringer KA; Whiterock A; Levitt PW; Petras J; Cohen M; Stoakes K; Daniels S; Sternberg C; Mazuz M; Frymoyer BS; Dickstein RA; Banger D; Kramer JH; Evans C; Victor M; Luhmann S; Worley WJ; Tuzi J; Janzer SF; Lysgaard JK; Stillabower ME; DiSabatino A; Voyce S; Keating D; Cohen M; Stoakes K; Zakrzewski M; Hayes C; Owens JS; Amburg C; Zatuchni J; Boyle M; Gheorghiade M; Mistovich M; Zayac J; DeGirolami D; Peterson D; Glick G; Reda A; Hueter D; Weszt S; Wynne J; Ladd DF; Mathew J; Davidson S; Borzak S; Cruz TA; Chiu C; Sedlarz P; Shanes JG; Calkins M; Alexander J; Steckel L; McKierman TL; Galbraith E; Sorkin RP; Moxley B; Sagar KB; Mauermann SK; Fairbairn JP; Walczak D; Willis PW; Boichot H; Barr LA; Burns A; Fintel D; Feiereisel P; Tommaso C; McDermott EV; Rosenson RS; Spokas D; AlHani A; Andrade M; Schreiber TL; Trevino C; Meisenbach JA; Bigler P; Evans J; Arslanian C; Rich S; Genthner DE; Eisenberg P; Fasholz JE; Chua KG; Schneider JM; Timmis GC; Golias R; Jafri S; Flandorfer C; Halperin J; Rothlauf E; Forman R; Furia S; Bhalodkar NC; Valeria A; Miller DA; Silvasi D; DeLeon J; Quyyami B; Mueller HS; Cosico J; Vorchheimer D; Guzman IC; Levin RI; Mele KA; Morrison J; Ward M; Gregory J; Romano J; Macina G; Kikel M; Kwan T; Julien R; Zeldis SM; Bilodeau SE; Comp P; Gates JL; Sigal SL; Oyer LF; Moss A; Brown M; Braden GA; Wesley DJ; Gillespie JA; Cohen L; Krone RJ; Humphrey JR; Bodenheimer MM; Kelly N; Lichstein E; Budzilowicz L; VanVoorhees L; Silverman A; Arora R; Blowers A; Greenberg H; McAnulty M; Hochman J; Goldstein RE; Shapiro S; Marcus FI; Gear K; Hall J; Faussett D; Border JF; Dinehart A; Atassi K; Smith F; Hahn R; ViellieuFischer B; Graham JD; Cheng WM; Rink LD; Satterfield JL; Slack JD; Burkert M; Tavel ME; Childress S; Sadiq RM; Sands P; Jennings M; Freestone J; Hall JH; Linden P; Lapp M; Habig E; Shelburne S; Khan S; Gray R; Defensor L; Fleisher JH; Patterson JA; Russell V; Karlsberg RP; Maccioni S; Cercek B; Conte S; Sowka L; Torgerson M; Levy MC; Alejandro PM; Polito S; Roll K; French WJ; Terrell D; Shook TL; Junio LN; Swan DA; Ujiiye D; Mahrer P; Noceda J; Kaushik V; Mueco A; Wallis J; Abrahamson D; Seiler B; Merz RH; Martin D; Ladenheim M; LozykZehr GM; Brodsky M; Chaim S; Bersohn MM; Silbar C; Pandian MG; Eldridge P; Lob IK; Smith C
Background Antiplatelet therapy with aspirin and systematic anticoagulation with warfarin reduce cardiovascular morbidity and mortality after myocardial infarction when given alone. In the Coumadin Aspirin Reinfarction Study (CARS), we aimed to find out whether a combination of low-dose warfarin and low-dose aspirin would give superior results to standard aspirin monotherapy without excessive bleeding risk. Methods We used a randomised double-blind study design. At 293 sites, we randomly assigned 8803 patients who had had myocardial infarction, treatment with 160 mg aspirin, 3 mg warfarin with 80 mg aspirin, or 1 mg warfarin with 80 mg aspirin. Patients took a single tablet daily, and attended for prothrombin time (PT) measurements at weeks 1, 2, 3, 4, 6, and 12, and then every 3 months. Patients were followed up for a maximum of 33 months (median 14 months). Findings The primary event was first occurrence of reinfarction, non-fatal ischaemic stroke, or cardiovascular death. 1-year life-table estimates for the primary event were 8.6% (95% Cl 7.6-9.6) for 160 mg aspirin, 8.4% (7.4-9.4) for 3 mg warfarin with 80 mg aspirin, and 8.8% (7.6-10) for 1 mg warfarin with 80 mg aspirin. Primary comparisons were done with all follow-up data. The relative risk of the primary event for the 160 mg aspirin group compared with the 3 mg warfarin with 80 mg aspirin group was 0.95 (0.81-1.12, p=0.57). For spontaneous major haemorrhage (not procedure related), 1-year life-table estimates were 0.74% (0.43-1.1) in the 160 mg aspirin group and 1.4% (0.94-1.8) in the 3 mg warfarin with 80 mg aspirin group (p=0.014 log rank on follow-up). For the 3382 patients assigned 3 mg warfarin with 80 mg aspirin, the INR results were: at week 1 (n=2985) median 1.51 (IQR 1.23-2.13); at week 4 (n=2701) 1.27 (1.13-1.64); at month 6 (n=2145) 1.19 (1.08-1.44). Interpretation Low, fixed-dose warfarin (1 mg or 3 mg) combined with low-dose aspirin (80 mg) in patients who have had myocardial infarction does not provide clinical benefit beyond that achievable with 160 mg aspirin monotherapy. $$:
ISI:A1997XQ24800008
ISSN: 0140-6736
CID: 130406

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

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; 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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 is less than or equal to 0.45. An ancillary study examines the effect in those with an ejection fraction > 0.45. 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. $$:
ISI:A1996UA39800009
ISSN: 0197-2456
CID: 108145