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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06307652




Registration number
NCT06307652
Ethics application status
Date submitted
6/02/2024
Date registered
13/03/2024
Date last updated
25/06/2024

Titles & IDs
Public title
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Scientific 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
Secondary ID [1] 0 0
D6402C00012
Universal Trial Number (UTN)
Trial acronym
BalanceD-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure and Impaired Kidney Function 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

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


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Timepoint [1] 0 0
Approximately 38 months
Secondary outcome [1] 0 0
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Timepoint [1] 0 0
Approximately 38 months
Secondary outcome [2] 0 0
Total occurrences (first and recurrent) of HF hospitalisations
Timepoint [2] 0 0
Approximately 38 months
Secondary outcome [3] 0 0
Time to CV death
Timepoint [3] 0 0
Approximately 38 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Approximately 24 weeks
Secondary outcome [5] 0 0
Time to death from any cause
Timepoint [5] 0 0
Approximately 38 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/06/2027
Actual
Sample size
Target
4800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Cairns
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Research Site - Canberra
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Research Site - Chermside
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Research Site - Clayton
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Research Site - Frankston
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Research Site - Geelong
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Research Site - Murdoch
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4870 - Cairns
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2605 - Canberra
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4032 - Chermside
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3168 - Clayton
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3199 - Frankston
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3220 - Geelong
Recruitment postcode(s) [8] 0 0
WA6150 - Murdoch
Recruitment outside Australia
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Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06307652
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06307652