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Taking people in GermanyPhase 3

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
Bad Nauheim, Bechhofen, Berlin, Bernau bei Berlin, Chemnitz, Coburg, Dresden, Elsterwerda, Frankfurt, Freiburg im Breisgau, Goslar, Göttingen, Hagen, Hamburg, Heidelberg, Kaiserslautern, Langen, Leipzig, Leverkusen, Mainz, Mönchengladbach, Münster, Paderborn, Papenburg, Regensburg, Rostock, Völklingen, Wermsdorf, and Witten, GermanySee the 29 sites
Phase
Phase 3

AI summary: who the study is looking for

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

Read by machine on 9 November 2026.

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 Germany

  • Bad NauheimHospital not named in the registryNo longer taking part
  • BechhofenHospital not named in the registryNo longer taking part
  • BerlinHospital not named in the registryTaking people
  • Bernau bei BerlinHospital not named in the registryNo longer taking part
  • ChemnitzHospital not named in the registryNo longer taking part
  • CoburgHospital not named in the registryTaking people
  • DresdenHospital not named in the registryNo longer taking part
  • ElsterwerdaHospital not named in the registryNo longer taking part
  • FrankfurtHospital not named in the registryNo longer taking part
  • Freiburg im BreisgauHospital not named in the registryTaking people
  • GoslarHospital not named in the registryTaking people
  • GöttingenHospital not named in the registryTaking people
  • HagenHospital not named in the registryTaking people
  • HamburgHospital not named in the registryTaking people
  • HeidelbergHospital not named in the registryTaking people
  • KaiserslauternHospital not named in the registryNo longer taking part
  • LangenHospital not named in the registryNo longer taking part
  • LeipzigHospital not named in the registryNo longer taking part
  • LeverkusenHospital not named in the registryNo longer taking part
  • MainzHospital not named in the registryTaking people
  • MönchengladbachHospital not named in the registryNo longer taking part
  • MünsterHospital not named in the registryNo longer taking part
  • PaderbornHospital not named in the registryNo longer taking part
  • PapenburgHospital not named in the registryTaking people
  • RegensburgHospital not named in the registryTaking people
  • Rostock, Mecklenburg-VorpommernHospital not named in the registryNo longer taking part
  • VölklingenHospital not named in the registryNo longer taking part
  • WermsdorfHospital not named in the registryNo longer taking part
  • WittenHospital not named in the registryNo longer taking part

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

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.

ClinicalTrials.gov NCT06307652 · EU CTIS 2023-508162-15-00