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
- Aracaju, Blumenau, Brasília, Campina Grande do Sul, Campinas, Curitiba, Goiânia, Niterói, Porto Alegre, Rio Branco, Rio de Janeiro, São José dos Campos, São Paulo, Teresina, and Uberlândia, BrazilSee the 15 sitesAlso in 38 other countries, 638 sites
- Trial code
- 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 Brazil
Also in 38 other countries, 638 sites
- AracajuHospital not named in the registryTaking people
- BlumenauHospital not named in the registryTaking people
- BrasíliaHospital not named in the registryTaking people
- Campina Grande do SulHospital not named in the registryTaking people
- CampinasHospital not named in the registryTaking people
- CuritibaHospital not named in the registryTaking people
- GoiâniaHospital not named in the registryTaking people
- NiteróiHospital not named in the registryNo longer taking part
- Porto AlegreHospital not named in the registryTaking people
- Rio BrancoHospital not named in the registryTaking people
- Rio de JaneiroHospital not named in the registryTaking people
- São José dos CamposHospital not named in the registryTaking people
- São PauloHospital not named in the registryNo longer taking part
- TeresinaHospital not named in the registryTaking people
- UberlândiaHospital 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
- 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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