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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (18 UK sites)
Research Site
Airdrie ML6 0JS, United Kingdom
Research Site
Barnet EN5 3DJ, United Kingdom
Research Site
Cambridge CB2 0AY, United Kingdom
Research Site
Clydebank G81 4DY, United Kingdom
Research Site
Exeter EX2 5DW, United Kingdom
Research Site
Harefield UB9 6JH, United Kingdom
Research Site
Hastings TN37 7RD, United Kingdom
Research Site
High Wycombe HP11 2TT, United Kingdom
Research Site
Kent BR6 8ND, United Kingdom
Research Site
Kings Lynn PE30 4ET, United Kingdom
Research Site
Lincoln LN2 5QY, United Kingdom
Research Site
London EC1M 6BQ, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Middlesbrough TS4 3BW, United Kingdom
Research Site
Portsmouth PO6 3LY, United Kingdom
Research Site
Sheffield S5 7AU, United Kingdom
Research Site
Sunderland SR4 7TP, United Kingdom
Research Site
Wakefield WF1 4DG, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
