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Double-Blind, Placebo-Controlled Study of the Efficacy of Flosequinan in Patients with Chronic Heart failure - REFLECT
Description:
Flosequinan for exercise tolerance in symptomatic CHF.
Hypothesis:
Flosequinan improves symptoms and exercise tolerance in patients with CHF who remain symptomatic on digitalis and diuretics.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 193
NYHA Class: II=(42%), III=(58%)
Mean Follow Up: 3 months
Mean Patient Age: 58
Female: 12
Mean Ejection Fraction: 26%
Patient Populations:
Symptomatic heart failure (above age 18)
LVEF < 40% and CT ratio > 50%
NYHA class II-III
Exercise duration 3-14 min despite digitalis/diuretics (modified Naughton protocol)
Exclusions:
Other vasodilator treatment including ACE inhibitor, hydralazine, nitrates, prazosin, calcium channel blockers
Valvular disease; pericardial disease on HCM
Systolic BP < 90 mmHg
Angina limiting exercise
Recent MI
Severe lung disease, renal or hepatic disease
Primary Endpoints:
Exercise tolerance at 12-week therapy
Drug/Procedures Used:
Flosequinan (100mg QD)
Concomitant Medications:
Diuretics (96%)
furosemide (100%)
Principal Findings:
Maximal treadmill exercise time increased by 96 seconds in flosequinan group and 47 seconds in placebo group (p = 0.22).
Maximum O2 consumption increased by 1.7 ml/kg/min in flosequinan group and 0.6 ml/kg/min in placebo group (p = 0.005).
Improved symptoms in 55% receiving flosequinan but only 36% placebo (p = 0.018).
Flosequinan resulted in a significant increase in supine and standing heart rate compared to placebo (p < 0.001).
Interpretation:
"These findings indicate that flosequinan is an effective drug for patients with chronic heart failure who remain symptomatic on digoxin and diuretics . . ." (From Abstract)
Subsequent mortality trial (see PROFILE) terminated early due to excessive deaths in flosequinan group.
References:
1. J Am Coll Cardiol 1993;22:65-72. Final results
Keywords: Exercise Tolerance, Digoxin, Diuretics, Heart Failure, Quinolines, Digitalis, Heart Rate, Vasodilator Agents, Exercise Test
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