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Withdrawal of Digoxin from Patients with Chronic Heart failure Treated with Angiotensin-Converting Enzyme Inhibitors - RADIANCE
Description:
Digoxin for systolic dysfunction in heart failure.
Hypothesis:
Digoxin therapy in heart failure with systolic dysfunction and normal sinus rhythm has an incremental benefit when added to a treatment regimen of angiotensin-converting enzyme inhibitors and diuretics.
Study Design
Study Design:
Patients Screened: Not available
Patients Enrolled: 1,556
NYHA Class: not given
Mean Follow Up: 1.5 months
Mean Patient Age: 64
Female: 28
Mean Ejection Fraction: not given
Patient Populations:
Symptomatic heart failure (NYHA functional class II-III)
LVEF < 35%
Echo > 60mm
Exercise duration 2-14 minutes (modified, Naughton protocol)
Treatment at least 3 months with digoxin, diuretic and ACE inhibitor
Exclusions:
Supraventricular or sustained ventricular arrhythmia
Primary Endpoints:
Effects of digoxin withdrawal on:
Rates of withdrawal from study due to worsening Congestive heart failure
Time to withdrawal from study
Changes in exercise tolerance
Secondary Endpoints:
Effects of digoxin withdrawal on:
Symptoms
Quality of life
Functional class
Patient's perception of progress
Cardiac dimensions and function (echo)
Drug/Procedures Used:
Digoxin
Enalapril
Captopril
Diuretics
Concomitant Medications:
Diuretics (100%)
ACE inhibitors (100%)
nitrates (33%)
Principal Findings:
Worsening CHF in 23 patients randomized to placebo but in only 4 patients remaining on digoxin. All measures of functional capacity deteriorated in placebo group compared to digoxin group. Lower quality of life scores, decreased ejection fraction and increased heart rate and body weight in patients withdrawn from digoxin.
Interpretation:
"These findings indicate that the withdrawal of digoxin carries considerable risks for patients with chronic heart failure and impaired systolic function who have remained clinically stable while receiving digoxin and angiotensin-converting enzyme inhibitors." (From Abstract)
References:
1. N Engl J Med 1993;329:1-7. Final results
2. J Am Coll Cardiol 1998;32:686-92. Review
Keywords: Enalapril, Digoxin, Quality of Life, Diuretics, Heart Failure, Body Weight, Heart Rate, Captopril
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