Under construction – not a live service
Sign in
Taking people in United StatesPhase 3

Tests balcinrenone with dapagliflozin in heart failure and kidney impairment

Tests balcinrenone with dapagliflozin in adults with heart failure and impaired kidneys.

Key facts

Who runs it
AstraZeneca
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 sitesAlso in 38 other countries, 509 sites
Registry title
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Status
Recruiting
Phase
Phase 3
People taking part
3,850 people, planned
Started
12 Apr 2024
Expected to end
16 Apr 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
  • balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
  • dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-term heart failure and reduced kidney function who had a heart failure event in the last 6 months.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Heart failure with symptoms (NYHA class II-IV), a recent heart failure event (hospital stay or urgent visit) within 6 months, and an eGFR of 20 to less than 60 mL/min/1.73 m2.
Earlier treatment
Must be on standard treatment for heart failure and kidney problems, and must not be taking an MRA.
Biomarker or test result
NT-proBNP above 300 pg/mL (above 600 pg/mL with atrial fibrillation or atrial flutter); potassium 5.0 mmol/L or lower; a LVEF value from the last 12 months.

Main reasons for not taking part

  • Heart attack, unstable angina, stroke or TIA in the last 3 months
  • Major heart surgery or heart device implant in the last 3 months
  • Type 1 diabetes
  • Kidney replacement therapy in the last 4 weeks or needed now
  • Severe liver disease

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

Also in 38 other countries, 509 sites

  • Abington, PennsylvaniaHospital not named in the registryTaking people
  • Albany, New YorkHospital not named in the registryNo longer taking part
  • Alexander City, AlabamaHospital not named in the registryTaking people
  • Alexandria, LouisianaHospital not named in the registryNo longer taking part
  • Allen, TexasHospital not named in the registryTaking people
  • Altamonte Springs, FloridaHospital not named in the registryNo longer taking part
  • Amarillo, TexasHospital not named in the registryTaking people
  • Anderson, South CarolinaHospital not named in the registryNo longer taking part
  • Ann Arbor, MichiganHospital not named in the registryNo longer taking part
  • Asheville, North CarolinaHospital not named in the registryTaking people
  • Atlanta, GeorgiaHospital not named in the registryTaking people
  • Augusta, GeorgiaHospital not named in the registryNo longer taking part
  • Aurora, ColoradoHospital not named in the registryTaking people
  • Beverly Hills, CaliforniaHospital not named in the registryTaking people
  • Birmingham, AlabamaHospital not named in the registryNo longer taking part
  • Bloomfield Hills, MichiganHospital not named in the registryTaking people
  • Boca Raton, FloridaHospital not named in the registryTaking people
  • Boston, MassachusettsHospital not named in the registryTaking people
  • Bradenton, FloridaHospital not named in the registryTaking people
  • Bridgewater, New JerseyHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryTaking people
  • Camp Hill, PennsylvaniaHospital not named in the registryTaking people
  • Chapel Hill, North CarolinaHospital not named in the registryTaking people
  • Charleston, West VirginiaHospital not named in the registryTaking people
  • Charlotte, North CarolinaHospital not named in the registryTaking people
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Clearwater, FloridaHospital not named in the registryNo longer taking part
  • Clifton Park, New YorkHospital not named in the registryTaking people
  • Columbia, MissouriHospital not named in the registryTaking people
  • Covina, CaliforniaHospital not named in the registryTaking people
  • Cypress, TexasHospital not named in the registryTaking people
  • Dallas, TexasHospital not named in the registryTaking people
  • Dayton, OhioHospital not named in the registryNo longer taking part
  • Dearborn, MichiganHospital not named in the registryNo longer taking part
  • Delray Beach, FloridaHospital not named in the registryTaking people
  • Durham, North CarolinaHospital not named in the registryTaking people
  • El Paso, TexasHospital not named in the registryTaking people
  • Elkhart, IndianaHospital not named in the registryTaking people
  • Encinitas, CaliforniaHospital not named in the registryNo longer taking part
  • Evansville, IndianaHospital not named in the registryTaking people
  • Fairhope, AlabamaHospital not named in the registryTaking people
  • Fall River, MassachusettsHospital not named in the registryNo longer taking part
  • Falls Church, VirginiaHospital not named in the registryTaking people
  • Farmington Hills, MichiganHospital not named in the registryNo longer taking part
  • Flint, MichiganHospital not named in the registryNo longer taking part
  • Fort Lauderdale, FloridaHospital not named in the registryTaking people
  • Gainesville, FloridaHospital not named in the registryTaking people
  • Glenview, IllinoisHospital not named in the registryNo longer taking part
  • Greensboro, North CarolinaHospital not named in the registryNo longer taking part
  • Hammond, LouisianaHospital not named in the registryNo longer taking part
  • Hazel Crest, IllinoisHospital not named in the registryTaking people
  • Henderson, NevadaHospital not named in the registryNo longer taking part
  • Hershey, PennsylvaniaHospital not named in the registryTaking people
  • Horsham, PennsylvaniaHospital not named in the registryNo longer taking part
  • Houston, TexasHospital not named in the registryNo longer taking part
  • Huntsville, TexasHospital not named in the registryTaking people
  • Indianapolis, IndianaHospital not named in the registryNo longer taking part
  • Jackson, MississippiHospital not named in the registryTaking people
  • Jacksonville, FloridaHospital not named in the registryTaking people
  • Jersey City, New JerseyHospital not named in the registryTaking people
  • Kansas City, MissouriHospital not named in the registryTaking people
  • Katy, TexasHospital not named in the registryNo longer taking part
  • Knoxville, TennesseeHospital not named in the registryTaking people
  • Ladson, South CarolinaHospital not named in the registryNo longer taking part
  • Lancaster, PennsylvaniaHospital not named in the registryTaking people
  • Lincoln, NebraskaHospital not named in the registryTaking people
  • Little Rock, ArkansasHospital not named in the registryTaking people
  • Los Angeles, CaliforniaHospital not named in the registryTaking people
  • Louisville, KentuckyHospital not named in the registryNo longer taking part
  • Manhasset, New YorkHospital not named in the registryNo longer taking part
  • Mansfield, TexasHospital not named in the registryNo longer taking part
  • Maumee, OhioHospital not named in the registryNo longer taking part
  • McKinney, TexasHospital not named in the registryTaking people
  • Memphis, TennesseeHospital not named in the registryTaking people
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Miami Lakes, FloridaHospital not named in the registryTaking people
  • Minneapolis, MinnesotaHospital not named in the registryNo longer taking part
  • Muncie, IndianaHospital not named in the registryTaking people
  • Munster, IndianaHospital not named in the registryTaking people
  • Nashville, TennesseeHospital not named in the registryTaking people
  • New Orleans, LouisianaHospital not named in the registryNo longer taking part
  • New Windsor, New YorkHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryTaking people
  • Newport Beach, CaliforniaHospital not named in the registryNo longer taking part
  • Newport News, VirginiaHospital not named in the registryTaking people
  • North Chicago, IllinoisHospital not named in the registryNo longer taking part
  • North Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Odessa, TexasHospital not named in the registryTaking people
  • Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
  • Orange, CaliforniaHospital not named in the registryNo longer taking part
  • Palm Beach Gardens, FloridaHospital not named in the registryTaking people
  • Peachtree City, GeorgiaHospital not named in the registryTaking people
  • Pearland, TexasHospital not named in the registryNo longer taking part
  • Pensacola, FloridaHospital not named in the registryTaking people
  • Peoria, IllinoisHospital not named in the registryTaking people
  • Philadelphia, PennsylvaniaHospital not named in the registryTaking people
  • Phoenix, ArizonaHospital not named in the registryTaking people
  • Pinehurst, North CarolinaHospital not named in the registryTaking people
  • Port Charlotte, FloridaHospital not named in the registryNo longer taking part
  • Portland, OregonHospital not named in the registryTaking people
  • Providence, Rhode IslandHospital not named in the registryTaking people
  • Puyallup, WashingtonHospital not named in the registryNo longer taking part
  • Rapid City, South DakotaHospital not named in the registryTaking people
  • Redding, CaliforniaHospital not named in the registryTaking people
  • Richmond, VirginiaHospital not named in the registryNo longer taking part
  • Rockville, MarylandHospital not named in the registryTaking people
  • Safety Harbor, FloridaHospital not named in the registryTaking people
  • Saint Augustine, FloridaHospital not named in the registryTaking people
  • Saint Paul, MinnesotaHospital not named in the registryTaking people
  • Salt Lake City, UtahHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryTaking people
  • San Diego, CaliforniaHospital not named in the registryTaking people
  • San Francisco, CaliforniaHospital not named in the registryTaking people
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • Seattle, WashingtonHospital not named in the registryNo longer taking part
  • Sherman, TexasHospital not named in the registryNo longer taking part
  • Shreveport, LouisianaHospital not named in the registryNo longer taking part
  • Somerset, New JerseyHospital not named in the registryTaking people
  • Springfield, MissouriHospital not named in the registryTaking people
  • St. Petersburg, FloridaHospital not named in the registryTaking people
  • Staten Island, New YorkHospital not named in the registryTaking people
  • Statesville, North CarolinaHospital not named in the registryNo longer taking part
  • Stony Brook, New YorkHospital not named in the registryNo longer taking part
  • Tacoma, WashingtonHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryTaking people
  • Temple, TexasHospital not named in the registryTaking people
  • The Bronx, New YorkHospital not named in the registryNo longer taking part
  • Thomasville, GeorgiaHospital not named in the registryNo longer taking part
  • Thousand Oaks, CaliforniaHospital not named in the registryNo longer taking part
  • Troy, MichiganHospital not named in the registryNo longer taking part
  • Tucker, GeorgiaHospital not named in the registryTaking people
  • Tullahoma, TennesseeHospital not named in the registryTaking people
  • Tyler, TexasHospital not named in the registryTaking people
  • Vista, CaliforniaHospital not named in the registryTaking people
  • Waterloo, IowaHospital not named in the registryTaking people
  • West Hills, CaliforniaHospital not named in the registryTaking people
  • West Monroe, LouisianaHospital not named in the registryTaking people
  • Wheat Ridge, ColoradoHospital not named in the registryNo longer taking part
  • Wichita, KansasHospital not named in the registryNo longer taking part
  • Wilmington, North CarolinaHospital not named in the registryTaking people
  • Winfield, IllinoisHospital not named in the registryTaking people
  • Worcester, MassachusettsHospital not named in the registryNo longer taking part
  • Ypsilanti, MichiganHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • balcinrenone/dapagliflozin 15 mg/10 mgTreatment being tested

    Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

    Treatment: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

  • balcinrenone/dapagliflozin 40 mg/10 mgTreatment being tested

    Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

    Treatment: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

  • dapagliflozin 10 mgExisting treatment, for comparison

    Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

    Treatment: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Questions to ask the study team

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

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests balcinrenone with dapagliflozin in heart failure and kidney impairmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06307652, who can take part
Record updated
13 October 2026