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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    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

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisationTo determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisationApproximately 38 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisationTo determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisationApproximately 38 months
    Total occurrences (first and recurrent) of HF hospitalisationsTo determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisationsApproximately 38 months
    Time to CV deathTo determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV deathApproximately 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-randomisationTo 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 HFApproximately 24 weeks
    Time to death from any causeTo determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any causeApproximately 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

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