Health Trials

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

ConditionHeart Failure and Impaired Kidney Function
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

3,850 Participants
are divided into 3 treatment groups
Group A: balcinrenone/dapagliflozin 15 mg/10 mgExperimental treatment 1 intervention
Group B: balcinrenone/dapagliflozin 40 mg/10 mgExperimental treatment 1 intervention
Group C: dapagliflozin 10 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Approximately 36 months

Secondary outcomes

1

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

Time frame
Approximately 36 months
2

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

Time frame
Approximately 36 months
3

Time to CV death

To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death

Time frame
Approximately 36 months
4

Time to death from any cause

To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause

Time frame
Approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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