Tests balcinrenone with dapagliflozin in heart failure and kidney impairment
Tests balcinrenone with dapagliflozin in adults with heart failure and impaired kidneys.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Key facts
- Where
- Biała Podlaska, Bielsko-Biala, Bydgoszcz, Chrzanów, Gdansk, Gdynia, Katowice, Kazimierza Wielka, Kędzierzyn-Koźle, Krakow, Lodz, Lublin, Olsztyn, Ostrów Mazowiecka, Piekary Śląskie, Poznan, Rzeszów, Szczecin, Tarnów, Torun, Tychy, Warsaw, Wroclaw, and Zabrze, PolandSee the 24 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 Poland
- Biała PodlaskaBiała Podlaska, PolandTaking people
- Bielsko-BialaBielsko-Biala, PolandNo longer taking part
- BydgoszczBydgoszcz, PolandNo longer taking part
- ChrzanówChrzanów, PolandTaking people
- GdanskGdansk, PolandTaking people
- GdyniaGdynia, PolandNo longer taking part
- KatowiceKatowice, PolandTaking people
- Kazimierza WielkaKazimierza Wielka, PolandTaking people
- Kędzierzyn-KoźleKędzierzyn-Koźle, PolandTaking people
- KrakowKrakow, PolandTaking people
- LodzLodz, PolandTaking people
- LublinLublin, PolandNo longer taking part
- OlsztynOlsztyn, PolandTaking people
- Ostrów MazowieckaOstrów Mazowiecka, PolandTaking people
- Piekary ŚląskiePiekary Śląskie, PolandTaking people
- PoznanPoznan, PolandNo longer taking part
- RzeszówRzeszów, PolandNo longer taking part
- SzczecinSzczecin, PolandTaking people
- TarnówTarnów, PolandTaking people
- TorunTorun, PolandTaking people
- TychyTychy, PolandTaking people
- WarsawWarsaw, PolandTaking people
- WroclawWroclaw, PolandNo longer taking part
- ZabrzeZabrze, PolandTaking 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.