Ukwehluleka kwenhliziyo nge-ejection fraction encishisiwe (HFrEF) kuwuhlobo olukhulu lokwehluleka kwenhliziyo, futhi Ucwaningo lwe-China HF lubonise ukuthi u-42% wokuhluleka kwenhliziyo e-China yi-HFrEF, nakuba amakilasi amaningana ajwayelekile okwelapha ezidakamizwa atholakalayo ku-HFrEF futhi anciphise ingozi. yokufa kanye nokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo ngezinga elithile. Kodwa-ke, iziguli zisengozini enkulu yokwehluleka kwenhliziyo okuphindaphindayo izehlakalo eziba zimbi kakhulu, ukufa kusasele ku-25% futhi ukubikezelwa kusalokhu kubi. Ngakho-ke, sisenesidingo esiphuthumayo sama-ejenti okwelapha amasha ekwelapheni i-HFrEF, kanye ne-Vericiguat, isivuseleli se-soluble guanylate cyclase (sGC) inoveli, sacwaningwa ocwaningweni lwe-VICTORIA ukuze kuhlolwe ukuthi i-Vericiguat ingathuthukisa yini ukubikezelwa kweziguli ezine-HFrEF. Ucwaningo luyi-multicenter, randomized, parallel-group, i-placebo-controlled, blind-blind, event-driven, phase III imiphumela yomtholampilo. Iqhutshwa ngaphansi kwesikhungo seVIGOR Centre eCanada ngokubambisana neDuke Clinical Research Institute, izikhungo ze-616 emazweni angu-42 nasezifundeni, kuhlanganise neYurophu, iJapane, i-China ne-United States, ibambe iqhaza kulolu cwaningo. Umnyango wethu wezifo zenhliziyo uhlonishwe ngokubamba iqhaza. Ingqikithi yeziguli ezingu-5,050 ezinokwehluleka kwenhliziyo okungapheli ezineminyaka engu-≥18 iminyaka, i-NYHA isigaba II-IV, i-EF <45%, namazinga aphezulu e-natriuretic peptide (NT-proBNP) phakathi nezinsuku ezingu-30 ngaphambi kokungahleliwe, futhi ababelaliswe esibhedlela ngenxa yokwehluleka kwenhliziyo. phakathi nezinyanga eziyi-6 ngaphambi kwe-randomization noma i-diuretics enikezwe nge-intravenously ngenxa yokwehluleka kwenhliziyo phakathi nezinyanga ze-3 ngaphambi kwe-randomization yabhaliswa ocwaningweni, bonke abathola i-ESC, i-AHA/ACC, kanye nemihlahlandlela yezwe/yesifunda ethile enconyiwe izinga lokunakekelwa. Iziguli zahlelwa ngokungahleliwe ngesilinganiso esingu-1:1 emaqenjini amabili futhi zanikezwaI-Vericiguat(n=2526) kanye ne-placebo (n=2524) ngaphezu kokwelashwa okujwayelekile, ngokulandelana.
Isiphetho esiyinhloko socwaningo kwakuyisiphetho esiyinhlanganisela sokufa kwenhliziyo noma ukulaliswa esibhedlela kwenhliziyo yokuqala; iziphetho zesibili zazihlanganisa izingxenye zokuphela okuyinhloko, ukulaliswa esibhedlela kwenhliziyo yokuqala nokulandelayo (izenzakalo zokuqala neziphindaphindiwe), ukuphela kwenhlanganisela yazo zonke izinkinga zokufa noma ukulaliswa esibhedlela kwenhliziyo, kanye nokufa kwembangela. Ekulandeleni okumaphakathi kwezinyanga eziyi-10.8, kube nokuncishiswa okungu-10% kwesiphetho esiyinhloko sokufa kwenhliziyo nemithambo yegazi noma ukulaliswa esibhedlela kokuqala kwenhliziyo eqenjini le-Vericiguat uma kuqhathaniswa neqembu le-placebo.