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Phase III/ Balcinrenone/Dapagliflozin Compared to Dapagliflozin/ Risk of Heart Failure and Death

UCI Specialty Area: Cardiology, Surgery
Principal Investigator: Dawn Lombardo
Official Title: BalanceD-HF - A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared to Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function
A Study On:
Heart - Cardiovascular Circulatory
Heart Failure
Kidney - Nephrology

Study 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.

Eligibility

  1. Age greater than or equal to 18 years
  2. Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
  3. Having had a recent HF event within 6 months (hospitalization or urgent visit)
  4. Have a LVEF value from an assessment within the last 12 months
  5. Managed with SoC therapy for HF and renal impairment according to local guidelines
  6. NT-proBNP must be greater than 300 pg/mL (greater than 600 pg/mL if concomitant atrial fibrillation or atrial flutter)
  7. Not taking an MRA
  8. An eGFR greater than or equal to 20 to less than 60 mL/min/1.73 m2
  9. Serum/plasma potassium greater than or equal to 3.5 mmol/L and less than or equal to 5.0 mmol/L
  1. Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
  2. 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
  3. History of hypertrophic obstructive cardiomyopathy
  4. Complex congenital heart disease or severe uncorrected primary valvular disease
  5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
  6. Systolic BP less than 100 mmHg, or symptomatic hypotension within the past 24 hours
  7. 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
  8. Type 1 diabetes mellitus
  9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
  10. 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 greater than 3 × ULN; or TBL greater than 2 × ULN at time of screening
  11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
  12. Treatment with strong or moderate CYP3A4 inhibitor or inducer
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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