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

PHASE3RECRUITING

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.

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Study details:

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 is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.

The study will be conducted at approximately 700 sites in approximately 40 countries globally.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 ≥ 3.5 mmol/L and ≤ 5.0 mmol/L

Exclusion criteria

Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months

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 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 < 100 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

Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-12

Primary completion: 2027-06-11

Study completion finish: 2027-06-11

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06307652

Intervention or treatment

DRUG: 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

Conditions

• Heart Failure and Impaired Kidney Function

Image related to Heart Failure and Impaired Kidney Function

Condition: Heart Failure and Impaired Kidney Function
DRUG: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg and other drugs
Canberra, Not Specified, Australia and more
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Canberra, Not Specified, Australia
Research Site
Chermside, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Research Site
Concord, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: balcinrenone/dapagliflozin 15 mg/10 mg 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	DRUG: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg 1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
EXPERIMENTAL: balcinrenone/dapagliflozin 40 mg/10 mg 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	DRUG: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg 1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
ACTIVE_COMPARATOR: dapagliflozin 10 mg 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	DRUG: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin 1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation	Approximately 38 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation	Approximately 38 months
Total occurrences (first and recurrent) of HF hospitalisations	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations	Approximately 38 months
Time to CV death	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death	Approximately 38 months
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF	Approximately 24 weeks
Time to death from any cause	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause	Approximately 38 months

Frequently Asked Questions

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References

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