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

Conditions

• Heart Failure and Impaired Kidney Function

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Apr 12, 2024

Status verified

Apr 2026

Primary completion

Jun 11, 2027

Completion

Jun 11, 2027

Study Design

Enrollment

4,800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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
• 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

Primary Outcome Measure

Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation [ Time Frame: Approximately 38 months ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (166)

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