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Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function (BalanceD-HF)

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ClinicalTrials.gov Identifier: NCT06307652
Recruitment Status : Recruiting
First Posted : March 13, 2024
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure and Impaired Kidney Function Drug: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg Drug: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg Drug: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin Phase 3

Detailed Description:

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.

Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

  1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
  2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
  3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule

The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.

The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 12, 2024
Estimated Primary Completion Date : June 11, 2027
Estimated Study Completion Date : June 11, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: 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
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
 Drug: 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
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
 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation


Secondary Outcome Measures :
  1. Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 38 months ]
    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06307652


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT06307652    
Other Study ID Numbers: D6402C00012
First Posted: March 13, 2024    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dapagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs