To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
The study is a randomized, double-blind, multicenter, parallel group, placebo-controlled trial of oral enoximone in approximately 700 subjects with advanced chronic heart failure of either ischemic or nonischemic etiology receiving optimal conventional heart failure therapy. Eligible subjects will be randomized in a 1:1 ratio to receive either enoximone or placebo at the Randomization Visit. The initial dose of study drug will be 25 mg t.i.d.(3xday) and will be administered immediately after randomization. Subjects who tolerate this initial dose will be continued on 25 mg t.i.d. for at least two weeks. After two weeks, eligible subjects will be titrated to 50 mg t.i.d. for the duration of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,800
Participants receive oral enoximone
Participants receive placebo to match enoximone
Time from randomization to all-cause mortality or cardiovascular hospitalization
Time frame: Baseline to Month 6
Change in Patient Global Assessment score
Improvement in quality of life assessed by the Patient Global Assessment patient-reported outcomes tool
Time frame: Baseline to Month 6
Change in Six-Minute Walk Test
Improvement in quality of life assessed by the Six-Minute Walk Test, a measure of submaximal exercise tolerance
Time frame: Baseline to Month 6
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