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pathology

Demonstrated benefit and harm

k

heart failure

versus placebo or no treatment

No demonstrated result for efficacy

Trial

control

p<0.05

harm

NS

MACH 1, 2000

mibefradil vs placebo

hospitalization for heart failure 0.85 [0.75; 0.97]

all-cause death 1.10 [0.96; 1.25]

cardiovascular death 1.08 [0.94; 1.24]

Trial

Treatments

Patients

Method

MACH 1, 2000

mibefradil titrated up to100mg daily (n=1295)

vs.

placebo (n=1295)

Patients with moderate to severe congestive heart failure (NYHA class II to IV and left ventricular fraction ,35%).pj

Double aveugle

Parallel groups

Sample size: 1295/1295

Primary endpoint: all-cause mortality

FU duration: 1.6 years

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