C4921003 - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)

Condition studied

Heart failure

Investigational medicinal product(s)

Eligibility

Primary endpoint

Hierarchical combination of: • Adjudicated clinical events through Week 36: CV death, WHF event resulting in hospitalization, WHF event resulting in intravenous diuretic during an urgent HF visit, WHF event resulting in oral diuretic intensification in an outpatient setting. • CFB in 6MWD at Week 36 • CFB in KCCQ-23 TSS at Week 36.

Endpoint detail

• Incidence of TEAEs and TESAEs., • CFB in KCCQ-23 TSS, CSS, and physical limitation at Week 36., • CFB in 6MWD at Week 36. • CPET substudy only: CFB in pVO2 at Week 36., • CFB in NT-proBNP at Week 36.