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Looking for participantsPhase3

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

Sponsor: AstraZeneca

NCT ID: NCT06307652

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (drug), balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg (drug), dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg — drug: 1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use · balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg — drug: 1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use · dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin — drug: 1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
3,850
Started
2024-04-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure and impaired kidney function
  • • Phase3 - 3,850 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with heart failure and impaired kidney function

Where?

  • • Airdrie - Research Site
  • • Barnet - Research Site
  • • Cambridge - Research Site
  • • Clydebank - Research Site
  • • +14 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Heart Failure and Impaired Kidney Function

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 130 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Age ≥ 18 years
  • ✓Documented diagnosis of causing symptoms 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 kidney impairment according to local guidelines

Who cannot take part

  • ✗Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the...
  • ✗History of hypertrophic obstructive cardiomyopathy
  • ✗Complex congenital heart disease or severe uncorrected primary valvular disease
  • ✗causing symptoms bradycardia or second- or third-degree heart block without a pacemaker
  • ✗Systolic BP \< 90 mmHg, or causing symptoms hypotension within the past 24 hours
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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 * 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 * Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours * 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 * Type 1 diabetes mellitus * Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy * 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 * Treatment with strong or moderate CYP3A4 inhibitor or inducer

Where Is This Study? (18 UK sites)

Research Site

Airdrie ML6 0JS, United Kingdom

Recruiting

Research Site

Barnet EN5 3DJ, United Kingdom

Recruiting

Research Site

Cambridge CB2 0AY, United Kingdom

WITHDRAWN

Research Site

Clydebank G81 4DY, United Kingdom

Recruiting

Research Site

Exeter EX2 5DW, United Kingdom

Recruiting

Research Site

Harefield UB9 6JH, United Kingdom

Recruiting

Research Site

Hastings TN37 7RD, United Kingdom

Recruiting

Research Site

High Wycombe HP11 2TT, United Kingdom

WITHDRAWN

Research Site

Kent BR6 8ND, United Kingdom

Recruiting

Research Site

Kings Lynn PE30 4ET, United Kingdom

Recruiting

Research Site

Lincoln LN2 5QY, United Kingdom

WITHDRAWN

Research Site

London EC1M 6BQ, United Kingdom

COMPLETED

Research Site

London SE5 9RS, United Kingdom

WITHDRAWN

Research Site

Middlesbrough TS4 3BW, United Kingdom

Recruiting

Research Site

Portsmouth PO6 3LY, United Kingdom

Recruiting

Research Site

Sheffield S5 7AU, United Kingdom

WITHDRAWN

Research Site

Sunderland SR4 7TP, United Kingdom

Recruiting

Research Site

Wakefield WF1 4DG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09