ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
- Conditions
- Heart Failure, Congestive
- Interventions
- Registration Number
- NCT00051285
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enoximone Enoximone - Placebo Enoximone placebo -
- Primary Outcome Measures
Name Time Method Time from randomization to all-cause mortality or cardiovascular hospitalization Baseline to Month 6
- Secondary Outcome Measures
Name Time Method Change in Patient Global Assessment score Baseline to Month 6 Improvement in quality of life assessed by the Patient Global Assessment patient-reported outcomes tool
Change in Six-Minute Walk Test Baseline to Month 6 Improvement in quality of life assessed by the Six-Minute Walk Test, a measure of submaximal exercise tolerance