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 ezingu-6 ngaphambi kwe-randomization noma i-diuretics enikezwe nge-intravenously ngenxa yokwehluleka kwenhliziyo phakathi nezinyanga ze-3 ngaphambi kwe-randomization yabhaliswa ocwaningweni, bonke bathola i-ESC, i-AHA/ACC, kanye nemihlahlandlela kazwelonke/yesifunda enconyiwe izinga lokunakekelwa.Iziguli zenziwe ngokungahleliwe ngesilinganiso esingu-1:1 kumaqembu amabili futhi zanikezwa i-Vericiguat (n=2526) ne-placebo (n=2524) phezu 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.

Ukuhlaziywa kweziphetho zesibili kubonise ukuncipha okuphawulekayo kokulaliswa esibhedlela sokuhluleka kwenhliziyo (HR 0.90) kanye nokunciphisa okuphawulekayo ekupheleni kwenhlanganisela yazo zonke izinkinga zokufa noma ukulaliswa esibhedlela kwenhliziyo (HR 0.90) eqenjini le-Vericiguat uma kuqhathaniswa neqembu le-placebo.

Imiphumela yocwaningo iphakamisa ukuthi ukungezwa kwe-Vericiguat ekwelapheni okujwayelekile kokwehluleka kwenhliziyo kunciphisa kakhulu ukwenzeka kwakamuva kwezigameko zokuhluleka kwenhliziyo eziwohlokayo futhi kunciphisa ubungozi bokuphela kwenhlanganisela yokufa kwenhliziyo noma ukulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo ezigulini ezine-HFrEF.Ikhono le-Vericiguat lokunciphisa ingozi yokuphela kwenhlanganisela yokufa kwenhliziyo noma ukuhluleka kwenhliziyo esibhedlela ezigulini ezinobungozi obukhulu bokuhluleka kwenhliziyo inikeza indlela entsha yokwelapha yokuhluleka kwenhliziyo futhi ivula izindlela ezintsha zokuhlola esikhathini esizayo isifo senhliziyo.I-Vericiguat okwamanje ayivunyelwe ukumakethwa.Ukuphepha, ukusebenza ngempumelelo kanye nokusebenza ngempumelelo kwezindleko zomuthi kusadingeka ukuthi kuqhutshekwe nokuhlolwa emakethe.