RecruitingHeart Failure and Impaired Kidney Function

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

Eligible age

18–130 yrs

Accepts

All genders

Locations

37 states

Healthy volunteers

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About this study

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.

Sponsor: AstraZeneca

You may qualify if…

✓ 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

You may not qualify if…

✕ 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