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document
Placebo-controlled study of oral enoximone in congestive heart failure with initial and final intravenous hemodynamic evaluation . Seventeen patients with stable congestive heart failure ( class II and III New York Heart Association ) received intravenous and oral enoximone in a 2-part study . Hemodynamic data were first obtained after intravenous administration of 0.75 mg/kg of enoximone ; data were again obtained after 12 weeks of therapy with either oral enoximone ( 150 mg 3 times daily ) or placebo . The efficacy and safety of oral enoximone were also studied in a 12-week , double-blind randomized format . In the intravenous study , enoximone was delivered over 5 minutes and hemodynamic data were measured for up to 12 hours after . Cardiac index increased 2.76 +/- 0.63 to 3.42 +/- 0.72 liters/min/m2 ) , pulmonary wedge pressure decreased ( 19.5 +/- 8.8 to 14.6 +/- 8.0 mm Hg ) as did mean arterial blood pressure ( 101 +/- 14.8 to 85 +/- 13.7 mm Hg ) and systemic vascular resistance ( 1,880 +/- 573 to 1,254 +/- 383 dynes s cm-5 ) . Heart rate increased slightly ( 82 +/- 17 to 86 +/- 14 beats/min ) . All these changes were maximal 1 to 2 hours after infusion and lasted 8 hours at least . Patients were then randomized double-blind to oral treatment . Baseline values showed that the 7 patients who received placebo had more severe CHF . Therefore , comparison might be biased . Patient overall assessment showed a continuous benefit in both groups . Ejection fraction improved from 30.1 +/- 6.8 % to 33.9 +/- 9.9 % in the enoximone group while it remained unchanged with placebo ( 23.4 +/- 6.5 % to 23.4 +/- 1.5 % ) . ( ABSTRACT TRUNCATED AT 250 WORDS )
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Intervention_Pharmacological
oral enoximone
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Intervention_Pharmacological
enoximone
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Intervention_Pharmacological
0.75 mg/kg of enoximone
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Intervention_Pharmacological
oral enoximone
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Intervention_Control
placebo
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Intervention_Pharmacological
oral enoximone
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Intervention_Pharmacological
enoximone
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Intervention_Control
placebo
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Outcome_Other
initial and final intravenous hemodynamic evaluation
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Outcome_Other
Hemodynamic data
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Outcome_Physical
Cardiac index
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Outcome_Physical
pulmonary wedge pressure
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Outcome_Physical
mean arterial blood pressure
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Outcome_Physical
systemic vascular resistance
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Outcome_Physical
Heart rate
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Outcome_Physical
CHF
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Participant_Sample-size
Seventeen patients
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Participant_Condition
stable congestive heart failure ( class II and III New York Heart Association )