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Randomized Study Assessing the Effect of Digoxin Withdrawal in Patients with Mild to Moderate Chronic Congestive Heart failure: Results of the PROVED - PROVED
Description:
Digoxin withdrawal for mortality in mild to moderate.
Hypothesis:
In patients with mild to moderate heart failure and normal sinus rhythm being treated with digoxin and diuretics, digoxin withdrawal results in increased heart failure symptoms and hospitalizations.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 88
NYHA Class: II=(83%), III=(17%)
Mean Follow Up: 3 months
Mean Patient Age: 64
Mean Ejection Fraction: 28%
Patient Populations:
Mild to moderate CHF
sinus rhythm
digoxin/diuretics used chronically
no ACE inhibitor
clinical CHF not caused by ischemia
EF < 35%
LVED > 60 mm
Exclusions:
Recent myocardial infarction (3 months)
unstable angina
stroke (12 months)
valvular disease
hypertrophic cardiomyopathy
uncontrolled arrhythmia
history of atrial fibrillation
Primary Endpoints:
Treadmill time on maximal exercise testing; distance covered during 6 minute walk; incidence of treatment failure; time to treatment failure.
Secondary Endpoints:
Change in signs/symptoms of congestive heart failure
Quality of life (living with congestive heart failure)
CHF score
7 point global evaluation of progress
LVEF (MUGA)
Echo dimensions
Vital signs
Body weight
Drug/Procedures Used:
Digoxin
furosemide
Concomitant Medications:
Diuretics (100%)
Principal Findings:
Digoxin withdrawal resulted in worsening exercise capacity and increased treatment failure.
Interpretation:
"These data provide strong evidence of the clinical efficacy of digoxin in patients with normal sinus rhythm and mild to moderate chronic heart failure secondary to systolic dysfunction who are treated with diuretics." (From Abstract)
References:
1. J Am Coll Cardiol 1993;22:955-62. Final results
2. J Am Coll Cardiol 1998;32:686-92. Review
Keywords: Treatment Failure, Digoxin, Diuretics, Heart Failure, Furosemide, Cardiotonic Agents
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