Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Key facts
- Where
- Abington, Albany, Alexander City, Alexandria, Allen, Altamonte Springs, Amarillo, Anderson, Ann Arbor, Asheville, Atlanta, Augusta, Aurora, Beverly Hills, Birmingham, Bloomfield Hills, Boca Raton, Boston, Bradenton, Bridgewater, Brooklyn, Camp Hill, Chapel Hill, Charleston, Charlotte, Chicago, Cincinnati, Clearwater, Clifton Park, Columbia, Covina, Cypress, Dallas, Dayton, Dearborn, Delray Beach, Durham, El Paso, Elkhart, Encinitas, Evansville, Fairhope, Fall River, Falls Church, Farmington Hills, Flint, Fort Lauderdale, Gainesville, Glenview, Greensboro, Hammond, Hazel Crest, Henderson, Hershey, Horsham, Houston, Huntsville, Indianapolis, Jackson, Jacksonville, Jersey City, Kansas City, Katy, Knoxville, Ladson, Lancaster, Lincoln, Little Rock, Los Angeles, Louisville, Manhasset, Mansfield, Maumee, McKinney, Memphis, Miami, Miami Lakes, Minneapolis, Muncie, Munster, Nashville, New Orleans, New Windsor, New York, Newport Beach, Newport News, North Chicago, North Las Vegas, Odessa, Oklahoma City, Orange, Palm Beach Gardens, Peachtree City, Pearland, Pensacola, Peoria, Philadelphia, Phoenix, Pinehurst, Port Charlotte, Portland, Providence, Puyallup, Rapid City, Redding, Richmond, Rockville, Safety Harbor, Saint Augustine, Saint Paul, Salt Lake City, San Antonio, San Diego, San Francisco, Santa Ana, Seattle, Sherman, Shreveport, Somerset, Springfield, St. Petersburg, Staten Island, Statesville, Stony Brook, Tacoma, Tampa, Temple, The Bronx, Thomasville, Thousand Oaks, Troy, Tucker, Tullahoma, Tyler, Vista, Waterloo, West Hills, West Monroe, Wheat Ridge, Wichita, Wilmington, Winfield, Worcester, and Ypsilanti, United StatesSee the 144 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Source: NCT06307652, who can take part
Where in United States
- AbingtonAbington, United StatesTaking people
- AlbanyAlbany, United StatesNo longer taking part
- Alexander CityAlexander City, United StatesTaking people
- AlexandriaAlexandria, United StatesNo longer taking part
- AllenAllen, United StatesTaking people
- Altamonte SpringsAltamonte Springs, United StatesNo longer taking part
- AmarilloAmarillo, United StatesTaking people
- AndersonAnderson, United StatesNo longer taking part
- Ann ArborAnn Arbor, United StatesNo longer taking part
- AshevilleAsheville, United StatesTaking people
- AtlantaAtlanta, United StatesTaking people
- AugustaAugusta, United StatesNo longer taking part
- AuroraAurora, United StatesTaking people
- Beverly HillsBeverly Hills, United StatesTaking people
- BirminghamBirmingham, United StatesNo longer taking part
- Bloomfield HillsBloomfield Hills, United StatesTaking people
- Boca RatonBoca Raton, United StatesTaking people
- BostonBoston, United StatesTaking people
- BradentonBradenton, United StatesTaking people
- BridgewaterBridgewater, United StatesNo longer taking part
- BrooklynBrooklyn, United StatesTaking people
- Camp HillCamp Hill, United StatesTaking people
- Chapel HillChapel Hill, United StatesTaking people
- CharlestonCharleston, United StatesTaking people
- CharlotteCharlotte, United StatesTaking people
- ChicagoChicago, United StatesNo longer taking part
- CincinnatiCincinnati, United StatesNo longer taking part
- ClearwaterClearwater, United StatesNo longer taking part
- Clifton ParkClifton Park, United StatesTaking people
- ColumbiaColumbia, United StatesTaking people
- CovinaCovina, United StatesTaking people
- CypressCypress, United StatesTaking people
- DallasDallas, United StatesTaking people
- DaytonDayton, United StatesNo longer taking part
- DearbornDearborn, United StatesNo longer taking part
- Delray BeachDelray Beach, United StatesTaking people
- DurhamDurham, United StatesTaking people
- El PasoEl Paso, United StatesTaking people
- ElkhartElkhart, United StatesTaking people
- EncinitasEncinitas, United StatesNo longer taking part
- EvansvilleEvansville, United StatesTaking people
- FairhopeFairhope, United StatesTaking people
- Fall RiverFall River, United StatesNo longer taking part
- Falls ChurchFalls Church, United StatesTaking people
- Farmington HillsFarmington Hills, United StatesNo longer taking part
- FlintFlint, United StatesNo longer taking part
- Fort LauderdaleFort Lauderdale, United StatesTaking people
- GainesvilleGainesville, United StatesTaking people
- GlenviewGlenview, United StatesNo longer taking part
- GreensboroGreensboro, United StatesNo longer taking part
- HammondHammond, United StatesNo longer taking part
- Hazel CrestHazel Crest, United StatesTaking people
- HendersonHenderson, United StatesNo longer taking part
- HersheyHershey, United StatesTaking people
- HorshamHorsham, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HuntsvilleHuntsville, United StatesTaking people
- IndianapolisIndianapolis, United StatesNo longer taking part
- JacksonJackson, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- Jersey CityJersey City, United StatesTaking people
- Kansas CityKansas City, United StatesTaking people
- KatyKaty, United StatesNo longer taking part
- KnoxvilleKnoxville, United StatesTaking people
- LadsonLadson, United StatesNo longer taking part
- LancasterLancaster, United StatesTaking people
- LincolnLincoln, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- LouisvilleLouisville, United StatesNo longer taking part
- ManhassetManhasset, United StatesNo longer taking part
- MansfieldMansfield, United StatesNo longer taking part
- MaumeeMaumee, United StatesNo longer taking part
- McKinneyMcKinney, United StatesTaking people
- MemphisMemphis, United StatesTaking people
- MiamiMiami, United StatesNo longer taking part
- Miami LakesMiami Lakes, United StatesTaking people
- MinneapolisMinneapolis, United StatesNo longer taking part
- MuncieMuncie, United StatesTaking people
- MunsterMunster, United StatesTaking people
- NashvilleNashville, United StatesTaking people
- New OrleansNew Orleans, United StatesNo longer taking part
- New WindsorNew Windsor, United StatesNo longer taking part
- New YorkNew York, United StatesTaking people
- Newport BeachNewport Beach, United StatesNo longer taking part
- Newport NewsNewport News, United StatesTaking people
- North ChicagoNorth Chicago, United StatesNo longer taking part
- North Las VegasNorth Las Vegas, United StatesNo longer taking part
- OdessaOdessa, United StatesTaking people
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- OrangeOrange, United StatesNo longer taking part
- Palm Beach GardensPalm Beach Gardens, United StatesTaking people
- Peachtree CityPeachtree City, United StatesTaking people
- PearlandPearland, United StatesNo longer taking part
- PensacolaPensacola, United StatesTaking people
- PeoriaPeoria, United StatesTaking people
- PhiladelphiaPhiladelphia, United StatesTaking people
- PhoenixPhoenix, United StatesTaking people
- PinehurstPinehurst, United StatesTaking people
- Port CharlottePort Charlotte, United StatesNo longer taking part
- PortlandPortland, United StatesTaking people
- ProvidenceProvidence, United StatesTaking people
- PuyallupPuyallup, United StatesNo longer taking part
- Rapid CityRapid City, United StatesTaking people
- ReddingRedding, United StatesTaking people
- RichmondRichmond, United StatesNo longer taking part
- RockvilleRockville, United StatesTaking people
- Safety HarborSafety Harbor, United StatesTaking people
- Saint AugustineSaint Augustine, United StatesTaking people
- Saint PaulSaint Paul, United StatesTaking people
- Salt Lake CitySalt Lake City, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- San FranciscoSan Francisco, United StatesTaking people
- Santa AnaSanta Ana, United StatesNo longer taking part
- SeattleSeattle, United StatesNo longer taking part
- ShermanSherman, United StatesNo longer taking part
- ShreveportShreveport, United StatesNo longer taking part
- SomersetSomerset, United StatesTaking people
- SpringfieldSpringfield, United StatesTaking people
- St. PetersburgSt. Petersburg, United StatesTaking people
- Staten IslandStaten Island, United StatesTaking people
- StatesvilleStatesville, United StatesNo longer taking part
- Stony BrookStony Brook, United StatesNo longer taking part
- TacomaTacoma, United StatesNo longer taking part
- TampaTampa, United StatesTaking people
- TempleTemple, United StatesTaking people
- The BronxThe Bronx, United StatesNo longer taking part
- ThomasvilleThomasville, United StatesNo longer taking part
- Thousand OaksThousand Oaks, United StatesNo longer taking part
- TroyTroy, United StatesNo longer taking part
- TuckerTucker, United StatesTaking people
- TullahomaTullahoma, United StatesTaking people
- TylerTyler, United StatesTaking people
- VistaVista, United StatesTaking people
- WaterlooWaterloo, United StatesTaking people
- West HillsWest Hills, United StatesTaking people
- West MonroeWest Monroe, United StatesTaking people
- Wheat RidgeWheat Ridge, United StatesNo longer taking part
- WichitaWichita, United StatesNo longer taking part
- WilmingtonWilmington, United StatesTaking people
- WinfieldWinfield, United StatesTaking people
- WorcesterWorcester, United StatesNo longer taking part
- 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?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06307652EU 2023-508162-15-00
- Record updated
- 13 October 2026
- Original description
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.Read full original descriptionShow less
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Inclusion: Age ≥ 18 years; Documented diagnosis of symptomatic HF (NYHA functional class II-IV); Having had a recent HF event within 6 months (hospitalization or urgent visit); Have a LVEF value from an assessment within the last 12 months; Managed with SoC therapy for HF and renal impairment according to local guidelines; NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter); Not taking an MRA; An eGFR ≥ 20 to < 60 mL/min/1.73 m2; Serum/plasma potassium ≤ 5.0 mmol/L.
Exclusion: Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period; Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations; Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment; Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy; Treatment with strong or moderate CYP3A4 inhibitor or inducer; History of hypertrophic obstructive cardiomyopathy; Complex congenital heart disease or severe uncorrected primary valvular disease; Symptomatic bradycardia or second- or third-degree heart block without a pacemaker; Type 1 diabetes mellitus; Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy; Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks; Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours.