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

NCT06307652
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
4,800
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Lead sponsor
AstraZeneca
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Start date
2024-04-12
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Number of sites
852
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Summary
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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Acronym
BalanceD-HF
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Short title
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
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Official title
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-06-11
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First posted
2024-03-13
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Registry last updated
2026-06-26
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Primary completion date
2027-06-11
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Start date
2024-04-12
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Participants
4,800
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Participant count basis
Estimated
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Planned participants
4,800
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Protocol amendments
2
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Randomisation ratio
1:1:1
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Number of sites
852
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06307652
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ClinicalTrials.gov ID
NCT06307652
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation

    Timeframe: Approximately 38 months

    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation

  1. Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation

    Timeframe: Approximately 38 months

    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

  2. Total occurrences (first and recurrent) of HF hospitalisations

    Timeframe: Approximately 38 months

    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations

  3. Time to CV death

    Timeframe: Approximately 38 months

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

  4. 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

    Timeframe: Approximately 24 weeks

    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

  5. Time to death from any cause

    Timeframe: Approximately 38 months

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No

  • 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 ≤ 5.0 mmol/L

  • 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
  • Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
  • Systolic BP < 90 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
  • Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
  • 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
Sources for eligibility
clinicaltrials.gov

  • Research SiteAlexander City, United StatesRecruiting
  • Research SiteBirmingham, United StatesWithdrawn
  • Research SiteFairhope, United StatesRecruiting
  • Research SiteHuntsville, United StatesRecruiting
  • Research SitePhoenix, United StatesRecruiting
  • Research SitePhoenix, United StatesRecruiting
  • Research SiteLittle Rock, United StatesRecruiting
  • Research SiteBeverly Hills, United StatesRecruiting
  • Research SiteCovina, United StatesRecruiting
  • Research SiteEncinitas, United StatesTerminated
  • Research SiteLos Angeles, United StatesRecruiting
  • Research SiteLos Angeles, United StatesRecruiting
  • Research SiteNewport Beach, United StatesTerminated
  • Research SiteOrange, United StatesWithdrawn
  • Research SiteRedding, United StatesRecruiting
  • Research SiteSan Diego, United StatesRecruiting
  • Research SiteSan Francisco, United StatesRecruiting
  • Research SiteSan Francisco, United StatesRecruiting
  • Research SiteSanta Ana, United StatesWithdrawn
  • Research SiteThousand Oaks, United StatesTerminated
  • Research SiteVista, United StatesRecruiting
  • Research SiteWest Hills, United StatesRecruiting
  • Research SiteAurora, United StatesRecruiting
  • Research SiteWheat Ridge, United StatesTerminated
  • Research SiteAltamonte Springs, United StatesTerminated

And 827 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-508162-15-00
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (18)