Phase
Condition
Heart Failure
Congestive Heart Failure
Heart Defect
Treatment
Placebo
Dapagliflozin
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥18 at the time of signing the informed consent
Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definitionof MI (Thygesen et al 2019), within the preceding 7 days, or 10 days if earlierrandomisation is not feasible
Evidence of impaired regional or global LV systolic function at any timepoint duringcurrent MI-related hospitalisation (established with echocardiogram, radionuclideventriculogram, contrast angiography or cardiac MRI) or definitive evidence on ECGof Q wave MI (defined as presence of Q waves in two or more contiguous leads,excluding leads III and aVR, and meeting all the following criteria: at least 1.5 mmin depth; at least 30 ms in duration; and, if R wave present, more than 25% of thesize of the subsequent R wave)
Hemodynamically stable at randomization (no episodes of symptomatic hypotension, orarrhythmia with haemodynamic compromise in the last 24 hours).
Male or female
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in theprotocol
Provision of signed and dated, written informed consent prior to any mandatory studyspecific procedures, sampling, and analyses
Exclusion
Exclusion Criteria:
Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission. Patientswith hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the indexevent, are eligible at the discretion of the Investigator. Patients who present withsigns and symptoms consistent with ketoacidosis, including nausea, vomiting,abdominal pain, malaise and shortness of breath should be assessed for ketoacidosis,and if ketoacidosis is confirmed the patient should not be randomized.
Chronic symptomatic HF with a prior HHF within the last year and known reducedejection fraction (LVEF≤40 %), documented before the current MI hospitalization
Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidlyprogressing renal disease at the time of randomization
Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into thetrial
Active malignancy requiring treatment at the time of screening, except for basalcell- or squamous cell carcinoma of the skin, presumed possible to treatsuccessfully
Any non-CV condition, eg malignancy, with a life expectancy of less than two yearsbased on the investigator´s clinical judgement
Currently on treatment, or with an indication for treatment, with a sodium glucoseco-transporter 2 inhibitor (SGLT2-inhibitor)
Study Design
Study Description
Connect with a study center
Research Site
Alingsås, 44183
SwedenSite Not Available
Research Site
Borås, 501 02
SwedenSite Not Available
Research Site
Enköping, 745 25
SwedenSite Not Available
Research Site
Eskilstuna, 631 88
SwedenSite Not Available
Research Site
Falun, 791 82
SwedenSite Not Available
Research Site
Gävle, 801 88
SwedenSite Not Available
Research Site
Göteborg, 416 85
SwedenSite Not Available
Research Site
Halmstad, 30185
SwedenSite Not Available
Research Site
Helsingborg, 251 87
SwedenSite Not Available
Research Site
Hässleholm, 281 25
SwedenSite Not Available
Research Site
Jönköping, 551 85
SwedenSite Not Available
Research Site
Kalix, 952 82
SwedenSite Not Available
Research Site
Karlshamn, 374 80
SwedenSite Not Available
Research Site
Karlskoga, 691 81
SwedenSite Not Available
Research Site
Karlskrona, 371 41
SwedenSite Not Available
Research Site
Karlstad, 651 85
SwedenSite Not Available
Research Site
Kiruna, 981 28
SwedenSite Not Available
Research Site
Köping, 731 81
SwedenSite Not Available
Research Site
Lidköping, 531 85
SwedenSite Not Available
Research Site
Linköping, 581 85
SwedenSite Not Available
Research Site
Luleå, 971 80
SwedenSite Not Available
Research Site
Lund, 222 42
SwedenSite Not Available
Research Site
Malmö, 205 02
SwedenSite Not Available
Research Site
Mölndal, 431 80
SwedenSite Not Available
Research Site
Norrköping, 603 79
SwedenSite Not Available
Research Site
Skellefteå, 931 86
SwedenSite Not Available
Research Site
Sollefteå, 881 04
SwedenSite Not Available
Research Site
Stockholm, 118 83
SwedenSite Not Available
Research Site
Sundsvall, 851 86
SwedenSite Not Available
Research Site
Trollhättan, 461 73
SwedenSite Not Available
Research Site
Umeå, 90737
SwedenSite Not Available
Research Site
Uppsala, 75185
SwedenSite Not Available
Research Site
Varberg, 43281
SwedenSite Not Available
Research Site
Visby, 621 55
SwedenSite Not Available
Research Site
Värnamo, 33185
SwedenSite Not Available
Research Site
Västerås, 723 35
SwedenSite Not Available
Research Site
Ystad, 271 82
SwedenSite Not Available
Research Site
Örebro, 701 85
SwedenSite Not Available
Research Site
Östersund, 831 83
SwedenSite Not Available
Research Site
Aberdeen, AB25 2ZN
United KingdomSite Not Available
Research Site
Ashford, TN24 0LZ
United KingdomSite Not Available
Research Site
Basildon, SS16 5NL
United KingdomSite Not Available
Research Site
Basingstoke, RG24 9NA
United KingdomSite Not Available
Research Site
Bath, BA1 3NG
United KingdomSite Not Available
Research Site
Belfast, BT12 6BA
United KingdomSite Not Available
Research Site
Birmingham, B9 5SS
United KingdomSite Not Available
Research Site
Blackburn, BB2 3HH
United KingdomSite Not Available
Research Site
Blackpool, FY3 8NR
United KingdomSite Not Available
Research Site
Bournemouth, BH7 7DW
United KingdomSite Not Available
Research Site
Bradford, BD9 6RJ
United KingdomSite Not Available
Research Site
Bridgend, CF31 1RQ
United KingdomSite Not Available
Research Site
Brighton, BN2 5BE
United KingdomSite Not Available
Research Site
Bristol, BS105NB
United KingdomSite Not Available
Research Site
Buckhurst Hill, IG9 5HX
United KingdomSite Not Available
Research Site
Cambridge, CB2 0AY
United KingdomSite Not Available
Research Site
Cardiff, CF14 4XW
United KingdomSite Not Available
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Clydebank, G81 4DY
United KingdomSite Not Available
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Coventry, CV2 2DX
United KingdomSite Not Available
Research Site
Dartford, DA2 8DA
United KingdomSite Not Available
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Derby, DE22 3NE
United KingdomSite Not Available
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Dundee, DD1 9SY
United KingdomSite Not Available
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East Kilbride, G75 8RG
United KingdomSite Not Available
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Edgbaston, B15 2WB
United KingdomSite Not Available
Research Site
Edinburgh, EH16 4SA
United KingdomSite Not Available
Research Site
Exeter, EX2 5DW
United KingdomSite Not Available
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Gillingham, ME7 5NY
United KingdomSite Not Available
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Glasgow, G4 0SF
United KingdomSite Not Available
Research Site
Halifax, HX3 0PW
United KingdomSite Not Available
Research Site
Harefield, UB9 6JH
United KingdomSite Not Available
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Harrow, HA1 3UJ
United KingdomSite Not Available
Research Site
Headington, OX3 9DU
United KingdomSite Not Available
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Hull, HU16 5JQ
United KingdomSite Not Available
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Kent, ME7 5NY
United KingdomSite Not Available
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Kettering, NN16 8UZ
United KingdomSite Not Available
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Leeds, LS13EX
United KingdomSite Not Available
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Leicester, LE3 9QP
United KingdomSite Not Available
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Lincoln, LN2 5QY
United KingdomSite Not Available
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Liverpool, L14 3PE
United KingdomSite Not Available
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London, SE5 9RS
United KingdomSite Not Available
Research Site
Manchester, M23 9LT
United KingdomSite Not Available
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Merthyr Tydfil, CF47 9DT
United KingdomSite Not Available
Research Site
Middlesborough, TS4 3BW
United KingdomSite Not Available
Research Site
Newcastle upon Tyne, NE7 7DN
United KingdomSite Not Available
Research Site
Newport, NP20 2UB
United KingdomSite Not Available
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Norwich, NR4 7UY
United KingdomSite Not Available
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Nottingham, NG5 1PB
United KingdomSite Not Available
Research Site
Plymouth, PL6 8DH
United KingdomSite Not Available
Research Site
Pontyclun, CF72 8XR
United KingdomSite Not Available
Research Site
Portsmouth, PO6 3LY
United KingdomSite Not Available
Research Site
Rhyl, LL18 5UJ
United KingdomSite Not Available
Research Site
Scarborough, YO12 6QL
United KingdomSite Not Available
Research Site
Sheffield, S5 7AU
United KingdomSite Not Available
Research Site
Southampton, SO166YD
United KingdomSite Not Available
Research Site
Stevenage, SG1 4AB
United KingdomSite Not Available
Research Site
Stoke on Trent, ST4 6QG
United KingdomSite Not Available
Research Site
Sunderland, SR4 7TP
United KingdomSite Not Available
Research Site
Swansea, SA6 6NL
United KingdomSite Not Available
Research Site
Taunton, TA1 5DA
United KingdomSite Not Available
Research Site
Torquay, TQ2 7AA
United KingdomSite Not Available
Research Site
Truro, TR1 3LJ
United KingdomSite Not Available
Research Site
Wakefield, WF1 4DG
United KingdomSite Not Available
Research Site
West Bromwich, B71 4HJ
United KingdomSite Not Available
Research Site
Wigan, WN1 2NN
United KingdomSite Not Available
Research Site
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Research Site
Worcester, WR5 1DD
United KingdomSite Not Available
Research Site
Worthing, BN11 2DH
United KingdomSite Not Available
Research Site
York, YO31 8HE
United KingdomSite Not Available
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