Danicamtiv

Evidence outlook · lead readout

NCT03447990 · Heart Failure With Reduced Ejection Fraction, Dilated Cardiomyopathy

The completed lead evidence is positive, with design limits that temper confidence — see the rationale below for exactly which.

NCT03447990: This study was a randomized, quadruple-blind, placebo-controlled phase 1/2 dose-escalation trial in 52 patients, but it was designed to assess safety, tolerability, PK, and pharmacodynamic signals rather than to test a clinical efficacy hypothesis. The primary outcome measures are descriptive safety endpoints with no reported statistical comparisons, and the sample size is small, so despite the sound blinding and control the evidence for danicamtiv is limited. Secondary echocardiographic findings were analyzed by plasma-concentration ranges and are exploratory rather than confirmatory.