A Phase III, Randomized, 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
Criteria:1. Participant must be ≥ 18 years old
2. Documented diagnosis of symptomatic HF (NYHA
functional Class II to IV), present before the last event.
3. Having had a recent HF event, defined as either:
a. A
hospitalization primarily for a HF indication including signs and symptoms of
congestions and use of parenteral medications for HF during admission within 6
months prior to randomization
b. An urgent HF
visit with outpatient parenteral medications for HF within 6 months prior to
randomization
c. Currently hospitalized
due to worsening of chronic HF, but with none of the following within the last
24 hours of randomization
i.
Invasive or non-invasive ventilation
ii.
IV vasopressor, IV vasodilator use including nitrates
or IV inotropes
iii.
Increase in dose of IV diuretics