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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 will be conducted at approximately 700 sites in approximately 40 countries globally."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares balcinrenone plus dapagliflozin with dapagliflozin alone, taken once a day along with usual care. It tests whether the combination lowers deaths from heart or blood vessel problems and heart failure events. It is for adults with long-term heart failure, reduced kidney function, and a recent heart failure hospital stay or urgent visit.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have heart failure with symptoms, rated class II to IV.
  • Had a hospital stay or urgent visit for heart failure in the past 6 months.
  • Had a test of how much blood the heart pumps out with each beat within the past 12 months.
  • Receive usual care for heart failure and kidney problems under local guidelines.
  • Have an NT-proBNP blood test result above 300 pg/mL, or above 600 pg/mL if you have atrial fibrillation or flutter, types of abnormal heartbeat.
  • Are not taking an MRA, a type of medicine used for heart failure.
  • Have an eGFR kidney filtering test result of 20 to less than 60 mL/min/1.73 m² and blood potassium of 5.0 mmol/L or less.

Who can't join

  • Had a heart attack, unstable chest pain, stroke, or mini-stroke in the past 3 months or during screening.
  • Had major heart surgery, a procedure to restore heart blood flow, valve repair or replacement, or a heart timing device placed in the past 3 months or during screening; or plan to have one.
  • Have a history of thick heart muscle that blocks blood flow, a complex heart problem present from birth, or severe valve disease that has not been corrected.
  • Have a slow heartbeat causing symptoms or certain blocked heart signals without a pacemaker; or have a top blood pressure number below 90 mmHg or low blood pressure symptoms in the past 24 hours.
  • Have primary high blood pressure in the lungs, long-term blood clots in the lungs, severe lung disease including COPD, or a COPD flare needing a breathing machine through a tube in the past 12 months.
  • Have type 1 diabetes; needed kidney replacement treatment, such as dialysis, in the past 4 weeks, need it now, or will need it soon; or have liver disease with severely reduced liver function.
  • Had suspected or confirmed COVID-19 in the past 4 weeks, or a hospital stay for COVID-19 in the past 12 weeks.
  • Take medicines that strongly or moderately change the activity of CYP3A4, a protein that helps the body break down medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 ≤ 5.0 mmol/L Exclusion Criteria: * 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

Study sites (166)

AL

AR

AZ

CA

CO

FL

GA

IA

IL

IN

KS

KY

LA

MA

MD

ME

MI

MN

MO

MS

NC

NE

NJ

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

TX

UT

VA

WA