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

Recruiting Phase 3 Interventional Study
Heart Failure and Impaired Kidney Function
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 130
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
4,800 (estimated)
Sponsor
AstraZeneca · Industry
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About This Trial

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.

Trial Locations
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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 i…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT