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Taking people in SlovakiaPhase 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
Banská Bystrica, Bratislava, Brezno, Košice, Martin, Myjava, Nitra, Nové Zámky, Považská Bystrica, Prešov, Rimavská Sobota, and Svidník, SlovakiaSee the 12 sitesAlso in 38 other countries, 641 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 Slovakia

Also in 38 other countries, 641 sites

  • Banská BystricaHospital not named in the registryTaking people
  • BratislavaHospital not named in the registryTaking people
  • BreznoHospital not named in the registryTaking people
  • KošiceHospital not named in the registryTaking people
  • MartinHospital not named in the registryTaking people
  • MyjavaHospital not named in the registryTaking people
  • NitraHospital not named in the registryTaking people
  • Nové ZámkyHospital not named in the registryNo longer taking part
  • Považská BystricaHospital not named in the registryTaking people
  • PrešovHospital not named in the registryNo longer taking part
  • Rimavská SobotaHospital not named in the registryNo longer taking part
  • SvidníkHospital 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