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

Study acronym: BalanceD-HF
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 20% 4800 → 3850 participants
See other at-risk trials from AstraZeneca

Record History

  1. Interventions: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and… to balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and… Eligibility criteria expanded, about 21 words · Secondary endpoints revised (5) · Site details revised at 9 of 852 sites · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints revised (5)
    • Site details revised at 9 of 852 sites
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  2. Enrollment reduced: 4800 → 3850 participants Primary and study completion moved earlier from Jun 11, 2027 to Apr 16, 2027 · Study description shortened, about 35 words · Site details revised at 394 of 852 sitesv26 Show 3 more changesShow less
    • Primary and study completion moved earlier from Jun 11, 2027 to Apr 16, 2027
    • Study description shortened, about 35 words
    • Site details revised at 394 of 852 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Trial sites expanded: 845 → 852 locationsv25
  4. Trial sites expanded: 842 → 845 locationsv24
  5. Site details revised at 24 of 842 sitesv23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 834 to 842v22
  2. Study sites: 824 to 834v21
  3. Study sites: 822 to 824v20
  4. Study sites: 815 to 822v19
  5. Study sites: 813 to 815 Eligibility criteria shortened, about 8 wordsv18 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 798 to 813v17
  7. Study sites: 793 to 798v16
  8. Study sites: 785 to 793v15
  9. Study sites: 760 to 785v14
  10. Study sites: 739 to 760v13
  11. Study sites: 719 to 739v12
  12. Study sites: 711 to 719v11
  13. Study sites: 710 to 711v10
  14. Study sites: 686 to 710v9
  15. Study sites: 678 to 686v8
  16. Study sites: 666 to 678v7
  17. Study sites: 654 to 666v6
  18. Study sites: 611 to 654v5
  19. Study sites: 588 to 611v4
  20. Study sites: 511 to 588v3
  21. Trial status: Not Yet Recruiting to Recruiting Study sites: 432 to 511 · Interventions: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and… to balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and… · Eligibility criteria revisedv2 Show 3 more changesShow less
    • Study sites: 432 to 511
    • Interventions: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and… to balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (Drug), balcinrenone/dapagliflozin 40 mg/10 mg and…
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Heart Failure
1,871 trials monitored
See 100 trials at risk
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.
Trial Details
NCT Number NCT06307652
Lead Sponsor AstraZeneca
Conditions Heart Failure and Impaired Kidney Function
Enrollment 3,850 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov