Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Imp… (NCT06307652) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
United States4,800 participantsStarted 2024-04-12
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation