Effects of low-dose oral enoximone administration on mortality, morbidity, and exercise capacity in patients with advanced heart failure: the randomized, double-blind, placebo-controlled, parallel group ESSENTIAL trials
Why the study?
Does low-dose oral enoximone improve clinical outcomes, exercise capacity, and symptoms in patients with advanced heart failure on background beta-blocker therapy?
Population
1,854 patients with advanced heart failure on beta-blockers and guideline-recommended background therapy…
Comparison
Low-dose oral enoximone added to… vs Placebo added to guideline-recommended…
Design
RCT, randomized, double-blind
Follow-up
6 months for functional endpoints; time-to-event for…
Authors
Discussion
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Implication
Low-dose enoximone should not be added in advanced HF on beta-blockers; confirms lack of benefit on mortality or hospitalization.
Structured PICO
Does low-dose oral enoximone improve clinical outcomes, exercise capacity, and symptoms in patients with advanced heart failure on background beta-blocker therapy?
P
Population
1,854 patients with advanced heart failure (NYHA class III-IV, LVEF ≤ 30%, and one hospitalization or two ambulatory visits for worsening HF in the previous year) on beta-blockers and guideline-recommended background therapy, multinational (211 sites in 16 countries).
I
Intervention
Low-dose oral enoximone added to guideline-recommended background therapy including beta-blockers.
C
Comparator
Placebo added to guideline-recommended background therapy including beta-blockers.
O
Outcome
Three co-primary endpoints: (i) composite of time to all-cause mortality or cardiovascular hospitalization; (ii) 6-month change from baseline in 6-minute walk test distance; (iii) Patient Global Assessment at 6 months.composite
Low-dose oral enoximone does not improve mortality, cardiovascular hospitalization, or symptoms in patients with advanced heart failure already receiving optimal medical therapy including beta-blockers.
Cite This Study
Metra et al. (2009) studied this question.