Multicenter Trial of Oral Enoximone in Patients with Moderate to Moderately Severe Congestive Heart failure - Enoximone Exercise

Feb 02, 2002
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Date Published:
01/01/1990
Date Updated:
02/02/2002
Original Posted Date:
02/02/2002
References

Description:

Enoximone vs. placebo for exercise tolerance in moderate CHF.

Hypothesis:

Enoximone in combination with digoxin and diuretics improves symptoms and exercise. tolerance in moderate to moderately severe heart failure.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 102
NYHA Class: II=(36%), III=(64%)
Mean Follow Up: 1.5 months
Mean Patient Age: 62
Female: 28
Mean Ejection Fraction: 22%

Patient Populations:

Clinical heart failure
Ability to exercise
Digoxin and diuretic therapy (long-term)

Exclusions:

Vasodilator therapy
Women of childbearing potential
Restrictive cardiomyopathy
Significant valvular disease
Myocardial infarction within 3 months
Symptomatic ventricular arrhythmias
Frequent angina
Evidence of severe pulmonary, hepatic, neurologic disease
Creatinine > 3.0mg/dl

Primary Endpoints:

Exercise duration
Symptoms (overall feeling of impairment, physicians global evaluation of impairment, daily activity scale, NYHA functional class)

Secondary Endpoints:

Severity of dyspnea/fatigue
Number of hospitalizations
Change in ejection fraction
Drop out rate/adverse events

Drug/Procedures Used:

Enoximone (mean dose 300 mg/day; could be titrated during study)
Digoxin/diuretics
Echocardiography performed at 6 weeks
Antiarrhythmic agents permitted
Exercise testing (modified Naughton protocol)
Oxygen consumption in subset of patients

Concomitant Medications:

Permitted to take antiarrhythmics, anticoagulants, K+ supplements

Principal Findings:

Enoximone in combination with digoxin and diuretics does not improve exercise

Dropout rate significantly greater with Enoximone (46%) non-placebo (25%)

With intention-to-treat analysis, 10 deaths in Enoximone group and 3 in placebo (p < 0.05).

Interpretation:

"The unexpectedly worse survival rate with Enoximone therapy raises concerns about a possible detrimental effect of Enoximone in the dose range given in this study." (From Abstract)

References:

1. Circulation 1990;82:774-80. Final Results

Keywords: Oxygen Consumption, Digoxin, Survival Rate, Diuretics, Intention to Treat Analysis, Heart Failure, Echocardiography, Cardiotonic Agents, Enoximone


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