Hypothesis
Clearing the parasite with benznidazole in patients with established Chagas cardiomyopathy would slow cardiac clinical deterioration.
What failed
Among 2,854 patients followed a mean 5.4 years, the composite cardiac outcome occurred in 27.5% vs 29.1% on placebo (HR 0.93, P=0.31).
Broken assumption
Clearing the parasite slows clinical progression once Chagas cardiomyopathy is established.
- Target engaged
- Yes
Why
The target was hit: blood PCR for T. cruzi turned negative in 66.2% vs 33.5% at the end of treatment. Reducing detectable parasite did not reduce clinical progression once cardiomyopathy was established.
From the published paper: Morillo CA, Marin-Neto JA, Avezum A, et al. (BENEFIT). N Engl J Med, 2015. NCT00123916 ↗