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March 25, 1982New England Journal of Medicine450 citations

Heart Failure in Outpatients

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DLDaniel Chia-Sen LeeRJRobert A. JohnsonJBJohn B. Bingham

Key Result

Oral digoxin reduced heart failure severity in 14 of 25 (56%) outpatients without atrial fibrillation, with a third heart sound being the strongest correlate of treatment response (P<0.0001).

Key Points

  • This study aims to evaluate the clinical benefits of digoxin in outpatients with heart failure without atrial fibrillation.
  • Randomized, double-blind, crossover design involving 25 outpatients.
  • Compared effects of oral digoxin and placebo using a clinicoradiographic scoring system.
  • Multivariate analysis to identify correlates of response to digoxin.
  • Digoxin reduced the severity of heart failure in 14 of 25 patients.
  • Nine of these had improvement confirmed by additional trials or right-heart catheterization.
  • Strongest correlate of response to digoxin was the presence of a third heart sound (P < 0.0001).

Study Design

Type

RCT (n=25)

Blinding

Double-blind

Randomization

Crossover

Structured PICO

Does oral digoxin reduce the severity of heart failure in outpatients without atrial fibrillation?

P
Population
25 outpatients with heart failure and sinus rhythm (without atrial fibrillation) whose failure persists despite diuretic treatment
I
Intervention
Oral digoxin
C
Comparator
Placebo
O
Outcome
Severity of heart failure according to a clinicoradiographic scoring systemsurrogate

Oral digoxin provides clinical benefit in heart failure patients in sinus rhythm, particularly those with severe disease and a third heart sound.

Abstract

The view that digitalis clinically benefits patients with heart failure and sinus rhythm lacks support from a well-controlled study. Using a randomized, double-blind, crossover protocol, we compared the effects of oral digoxin and placebo on the clinical courses of 25 outpatients without atrial fibrillation. According to a clinicoradiographic scoring system, the severity of heart failure was reduced by digoxin in 14 patients; in nine of these 14, improvement was confirmed by repeated trials (five patients) or right-heart catheterization (four patients). The other 11 patients had no detectable improvement from digoxin. Patients who responded to digoxin had more chronic and more severe heart failure, greater left ventricular dilation and ejection-fraction depression, and a third heart sound. Multivariate analysis showed that the third heart sound was the strongest correlate of the response to digoxin (P less than 0.0001). These data suggest that long-term digoxin therapy is clinically beneficial in patients with heart failure unaccompanied by atrial fibrillation whose failure persists despite diuretic treatment and who have a third heart sound.

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Cite This Study

Lee et al. (1982) conducted an RCT in Heart failure without atrial fibrillation (n=25). Oral digoxin vs. Placebo was evaluated on Severity of heart failure according to a clinicoradiographic scoring system. Oral digoxin reduced heart failure severity in 14 of 25 (56%) outpatients without atrial fibrillation, with a third heart sound being the strongest correlate of treatment response (P<0.0001).

synapsesocial.com/papers/6a0ef7d225c30b2cc7f9fbc2https://doi.org/10.1056/nejm198203253061202
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