Taking people in United StatesPhase 3

Tests baxdrostat with dapagliflozin to prevent heart failure in people with diabetes

Tests baxdrostat added to dapagliflozin in adults with type 2 diabetes and heart disease.

Plain-language title generated from the registry record
Registry title: Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Key facts

Where: Abilene, Albany, Albuquerque, Alexandria, Anchorage, Arlington, Atlanta, Aurora, Austin, Baltimore, Beaumont, Beavercreek, Beltsville, Birmingham, Boca Raton, Bossier City, Boston, Bridgeport, Brooklyn, Brownsville, Burke, Burlington, Camp Hill, Canton, Carson City, Centreville, Champaign, Charlotte, Charlottesville, Chicago, Cincinnati, Clearfield, Cleveland, Columbia, Columbus, Concord, Cordele, Crystal River, Dallas, Daly City, Dayton, Dublin, Duncanville, Durham, Eatontown, El Dorado, El Paso, Englewood, Fairfax, Fairhope, Falls Church, Fargo, Farmington Hills, Fayetteville, Flint, Fort Lauderdale, Fort Mill, Fort Myers, Franklinton, Gainesville, Gilbert, Glendale, Goose Creek, Green Bay, Greenville, Gurnee, Horsham, Houston, Huntington Beach, Huntsville, Idaho Falls, Indianapolis, Inglewood, Island Lake, Jacksonville, Kalispell, Kansas City, Kernersville, Kingwood, Kinston, La Jolla, Lakeland, Lakewood, Lenexa, Lewisville, Lexington, Lincoln, Loma Linda, Los Angeles, Louisville, Lutherville-Timonium, Manassas, Mankato, Mansfield, Massapequa, Maumee, McAllen, Medford, Mesquite, Miami, Miami Lakes, Midlothian, Milwaukee, Minneapolis, Missoula, Mobile, Monroe, Morganton, Morgantown, Morristown, Mt. Pleasant, Munster, Nashville, New Bedford, New Bern, New York, Newton, Norfolk, Norman, North Charleston, Ocoee, Ogden, Oklahoma City, Olla, Omaha, Orlando, Owensboro, Paducah, Palmetto Bay, Paris, Park Ridge, Pearland, Pennington, Philadelphia, Portsmouth, Potomac, Puyallup, Queens Village, Raleigh, Redmond, Renton, Richmond, Riverview, Rocky Mount, Roslindale, Sacramento, Saint Augustine, Salem, San Antonio, San Diego, San Dimas, San Francisco, Santa Maria, Scottdale, Sheffield, Sherman Oaks, Shreveport, Smithfield, Somerset, South Bend, Spartanburg, St Louis, Stamford, Stephenville, Sugar Land, Suwanee, Tempe, Thousand Oaks, Toledo, Tomball, Troy, Tucker, Tucson, Vestavia Hills, Victoria, Waterbury, Weslaco, West Chester, Wichita, Wilmington, Woodstock, Woodway, and Ypsilanti, United StatesSee the 183 sites
Phase: Phase 3

Where in United States

AbileneAbilene, United StatesTaking people
AlbanyAlbany, United StatesNo longer taking part
AlbuquerqueAlbuquerque, United StatesTaking people
AlexandriaAlexandria, United StatesTaking people
AnchorageAnchorage, United StatesNo longer taking part
ArlingtonArlington, United StatesNot yet recruiting
AtlantaAtlanta, United StatesTaking people
AuroraAurora, United StatesTaking people
AustinAustin, United StatesTaking people
BaltimoreBaltimore, United StatesTaking people
BeaumontBeaumont, United StatesTaking people
BeavercreekBeavercreek, United StatesTaking people
BeltsvilleBeltsville, United StatesTaking people
BirminghamBirmingham, United StatesTaking people
Boca RatonBoca Raton, United StatesNot yet recruiting
Bossier CityBossier City, United StatesTaking people
BostonBoston, United StatesTaking people
BridgeportBridgeport, United StatesTaking people
BrooklynBrooklyn, United StatesTaking people
BrownsvilleBrownsville, United StatesTaking people
BurkeBurke, United StatesTaking people
BurlingtonBurlington, United StatesNo longer taking part
Camp HillCamp Hill, United StatesTaking people
CantonCanton, United StatesTaking people
Carson CityCarson City, United StatesTaking people
CentrevilleCentreville, United StatesTaking people
ChampaignChampaign, United StatesTaking people
CharlotteCharlotte, United StatesTaking people
CharlottesvilleCharlottesville, United StatesTaking people
ChicagoChicago, United StatesTaking people
CincinnatiCincinnati, United StatesTaking people
ClearfieldClearfield, United StatesTaking people
ClevelandCleveland, United StatesTaking people
ColumbiaColumbia, United StatesTaking people
ColumbusColumbus, United StatesTaking people
ConcordConcord, United StatesNot yet recruiting
CordeleCordele, United StatesTaking people
Crystal RiverCrystal River, United StatesTaking people
DallasDallas, United StatesTaking people
Daly CityDaly City, United StatesNot yet recruiting
DaytonDayton, United StatesTaking people
DublinDublin, United StatesNo longer taking part
DuncanvilleDuncanville, United StatesTaking people
DurhamDurham, United StatesTaking people
EatontownEatontown, United StatesNo longer taking part
El DoradoEl Dorado, United StatesTaking people
El PasoEl Paso, United StatesTaking people
EnglewoodEnglewood, United StatesTaking people
FairfaxFairfax, United StatesTaking people
FairhopeFairhope, United StatesTaking people
Falls ChurchFalls Church, United StatesTaking people
FargoFargo, United StatesTaking people
Farmington HillsFarmington Hills, United StatesTaking people
FayettevilleFayetteville, United StatesTaking people
FlintFlint, United StatesTaking people
Fort LauderdaleFort Lauderdale, United StatesNo longer taking part
Fort MillFort Mill, United StatesTaking people
Fort MyersFort Myers, United StatesTaking people
FranklintonFranklinton, United StatesNot yet recruiting
GainesvilleGainesville, United StatesNo longer taking part
GilbertGilbert, United StatesTaking people
GlendaleGlendale, United StatesNo longer taking part
Goose CreekGoose Creek, United StatesNot yet recruiting
Green BayGreen Bay, United StatesNo longer taking part
GreenvilleGreenville, United StatesNot yet recruiting
GurneeGurnee, United StatesTaking people
HorshamHorsham, United StatesTaking people
HoustonHouston, United StatesNot yet recruiting
Huntington BeachHuntington Beach, United StatesTaking people
HuntsvilleHuntsville, United StatesTaking people
Idaho FallsIdaho Falls, United StatesTaking people
IndianapolisIndianapolis, United StatesTaking people
InglewoodInglewood, United StatesTaking people
Island LakeIsland Lake, United StatesTaking people
JacksonvilleJacksonville, United StatesTaking people
KalispellKalispell, United StatesNo longer taking part
Kansas CityKansas City, United StatesTaking people
KernersvilleKernersville, United StatesNo longer taking part
KingwoodKingwood, United StatesTaking people
KinstonKinston, United StatesTaking people
La JollaLa Jolla, United StatesTaking people
LakelandLakeland, United StatesTaking people
LakewoodLakewood, United StatesNo longer taking part
LenexaLenexa, United StatesTaking people
LewisvilleLewisville, United StatesNo longer taking part
LexingtonLexington, United StatesTaking people
LincolnLincoln, United StatesTaking people
Loma LindaLoma Linda, United StatesTaking people
Los AngelesLos Angeles, United StatesTaking people
LouisvilleLouisville, United StatesTaking people
Lutherville-TimoniumLutherville-Timonium, United StatesTaking people
ManassasManassas, United StatesTaking people
MankatoMankato, United StatesTaking people
MansfieldMansfield, United StatesNo longer taking part
MassapequaMassapequa, United StatesTaking people
MaumeeMaumee, United StatesTaking people
McAllenMcAllen, United StatesTaking people
MedfordMedford, United StatesNo longer taking part
MesquiteMesquite, United StatesTaking people
MiamiMiami, United StatesTaking people
Miami LakesMiami Lakes, United StatesTaking people
MidlothianMidlothian, United StatesTaking people
MilwaukeeMilwaukee, United StatesNo longer taking part
MinneapolisMinneapolis, United StatesTaking people
MissoulaMissoula, United StatesTaking people
MobileMobile, United StatesTaking people
MonroeMonroe, United StatesTaking people
MorgantonMorganton, United StatesNot yet recruiting
MorgantownMorgantown, United StatesTaking people
MorristownMorristown, United StatesTaking people
Mt. PleasantMt. Pleasant, United StatesTaking people
MunsterMunster, United StatesTaking people
NashvilleNashville, United StatesTaking people
New BedfordNew Bedford, United StatesNo longer taking part
New BernNew Bern, United StatesTaking people
New YorkNew York, United StatesTaking people
NewtonNewton, United StatesTaking people
NorfolkNorfolk, United StatesTaking people
NormanNorman, United StatesNo longer taking part
North CharlestonNorth Charleston, United StatesTaking people
OcoeeOcoee, United StatesNo longer taking part
OgdenOgden, United StatesTaking people
Oklahoma CityOklahoma City, United StatesTaking people
OllaOlla, United StatesNot yet recruiting
OmahaOmaha, United StatesTaking people
OrlandoOrlando, United StatesTaking people
OwensboroOwensboro, United StatesTaking people
PaducahPaducah, United StatesTaking people
Palmetto BayPalmetto Bay, United StatesTaking people
ParisParis, United StatesTaking people
Park RidgePark Ridge, United StatesTaking people
PearlandPearland, United StatesNo longer taking part
PenningtonPennington, United StatesTaking people
PhiladelphiaPhiladelphia, United StatesTaking people
PortsmouthPortsmouth, United StatesNo longer taking part
PotomacPotomac, United StatesTaking people
PuyallupPuyallup, United StatesNot yet recruiting
Queens VillageQueens Village, United StatesTaking people
RaleighRaleigh, United StatesTaking people
RedmondRedmond, United StatesTaking people
RentonRenton, United StatesTaking people
RichmondRichmond, United StatesTaking people
RiverviewRiverview, United StatesNot yet recruiting
Rocky MountRocky Mount, United StatesTaking people
RoslindaleRoslindale, United StatesTaking people
SacramentoSacramento, United StatesTaking people
Saint AugustineSaint Augustine, United StatesTaking people
SalemSalem, United StatesTaking people
San AntonioSan Antonio, United StatesTaking people
San DiegoSan Diego, United StatesTaking people
San DimasSan Dimas, United StatesTaking people
San FranciscoSan Francisco, United StatesTaking people
Santa MariaSanta Maria, United StatesTaking people
ScottdaleScottdale, United StatesTaking people
SheffieldSheffield, United StatesTaking people
Sherman OaksSherman Oaks, United StatesNo longer taking part
ShreveportShreveport, United StatesTaking people
SmithfieldSmithfield, United StatesTaking people
SomersetSomerset, United StatesTaking people
South BendSouth Bend, United StatesTaking people
SpartanburgSpartanburg, United StatesTaking people
St LouisSt Louis, United StatesTaking people
StamfordStamford, United StatesTaking people
StephenvilleStephenville, United StatesTaking people
Sugar LandSugar Land, United StatesTaking people
SuwaneeSuwanee, United StatesTaking people
TempeTempe, United StatesTaking people
Thousand OaksThousand Oaks, United StatesTaking people
ToledoToledo, United StatesTaking people
TomballTomball, United StatesTaking people
TroyTroy, United StatesTaking people
TuckerTucker, United StatesTaking people
TucsonTucson, United StatesTaking people
Vestavia HillsVestavia Hills, United StatesTaking people
VictoriaVictoria, United StatesNot yet recruiting
WaterburyWaterbury, United StatesTaking people
WeslacoWeslaco, United StatesTaking people
West ChesterWest Chester, United StatesNo longer taking part
WichitaWichita, United StatesNot yet recruiting
WilmingtonWilmington, United StatesTaking people
WoodstockWoodstock, United StatesTaking people
WoodwayWoodway, United StatesTaking people
YpsilantiYpsilanti, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: AstraZeneca
Trial code: NCT06677060 EU 2024-514506-32-00
Record updated: 21 October 2026
Original description: Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.Read full original descriptionShow less
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.
The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.
Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.
Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.
In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Inclusion: Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent; Diagnosed with T2DM and requiring treatment; Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease); History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit; At least one additional risk factor for HF:; Age ≥ 70 years; UACR > 20 mg/g; eGFR < 60 mL/min/1.73 m2; History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease); History of atrial fibrillation or atrial flutter; NT-proBNP > 125 ng/L.
Exclusion: Previously confirmed diagnosis and treatment of heart failure; Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation; Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation; Percutaneous coronary intervention within 1 month prior to randomisation; Any dialysis (including for acute kidney injury) within 3 months prior to screening; Any acute kidney injury within 3 months prior to screening; Prohibited concomitant medications; Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history; Documented history of adrenal insufficiency; An eGFR < 30 mL/min/1.73 m2 at screening; Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening; Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening; Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment.
ClinicalTrials.gov NCT06677060 · EU CTIS 2024-514506-32-00