Double-Blind Placebo-Controlled Study of Ibopamine and Digoxin in Patients with Mild to Moderate Heart failure: Results of the Dutch Ibopamine Multic - DIMT

Jan 31, 2002
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Date Published:
01/01/1993
Date Updated:
01/31/2002
Original Posted Date:
01/31/2002
References

Description:

Ibopamine for exercise capacity in stable heart failure.

Hypothesis:

Ibopamine is clinically effective in patients with stable heart failure.

Study Design

Study Design:

Patients Screened: 180
Patients Enrolled: 161
NYHA Class: II=(80%), III=(20%)
Mean Follow Up: 6 months
Mean Patient Age: 61
Female: 14
Mean Ejection Fraction: 29%

Patient Populations:

Signs/symptoms of CHF
Ages 18-75
Stable on oral meds for > 2 weeks (maximum of furosemide 80mg QD allowed)
MUGA ejection fraction < 45% (within prior 2 months)
Ability to exercise (bicycle) < 4 minutes

Exclusions:

Valvular or congenital heart disease
Myocarditis
Thyroid disease
Hypertrophic cardiomyopathy
Recent myocardial infarction
Exercise limiting angina
COPD limiting exercise capacity
Diabetes

Primary Endpoints:

Exercise capacity

Secondary Endpoints:

Neurohormonal
Perceived exertion after each exercise stage

Drug/Procedures Used:

Ibopamine 100 mg TID
Furosemide up to 80 mg QD

Concomitant Medications:

Furosemide (100%)
Triampterine (27%)
Antiarrhythmics (11%)
Anticoagulants (41%)
Antiplatelet (39%)

Principal Findings:

Six of 53 patients taking ibopamine dropped out due to increased congestive heart failure; 0/55 on digoxin.

Exercise time decreased in patients treated with placebo after 6 months (median -62 seconds; p less than 0.05 vs baseline), but it increased with ibopamine (+48 seconds), and digoxin (+17 seconds; both p less than 0.05 vs placebo).

Plasma norepinephrine and renin were significantly decreased by digoxin and ibopamine.

Functional class, ambulatory arrhythmias, and mortality were not significantly affected by either drug.

Interpretation:

"Even in stable, untreated heart failure, a small but significant progression of disease occurs during 6 months, as reflected by both clinical and neurohumoral changes. Both ibopamine and digoxin monotherapy may favorably affect these changes, and may thus be of value in this patient group."

References:

1. J Am Coll Cardiol 1993;22:1564-73. Final results
2. Am J Cardiol 1995;75:796-800. 6-month neurohormonal effects
3. J Am Coll Cardiol 1995;26:983-90. Heart rate variability

Keywords: Deoxyepinephrine, Renin, Digoxin, Diuretics, Norepinephrine, Furosemide, Vasodilator Agents, Heart Failure, Cardiotonic Agents


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