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European Heart Journal 1997 18(1):31-40;
Copyright © 1997 by the European Society of Cardiology.
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© 1997 The European Society of Cardiology

Doppler flow and echocardiography in functional cardiac insufficiency: Assessment of nisoldipine therapy

Results of the DEFIANT-II study

The DEFIANT-II Research Group

Abstract

Aims A multicentre, double-blind, placebo-controlled trial was conducted in 542 patients, randomized 7–10 days after myocardial infarction, to study the effect of nisoldipine coat-core (nisoldipine-CC) on exercise after 6 months. Secondary endpoints included exercise-induced ischaemia, left ventricular function measured by Doppler echocardiography, adverse cardiac events and clinical outcome.

Methods and results Patients had reduced left ventricular ejection fraction between 25 and 50%, but no heart failure. Exercise time was not different in the two groups. Nisoldipine-CC prolonged time to 1 mm ST deviation (P=0·03). There was an effect of nisoldipine-CC of +3·6cm. s–1 on early peak velocity (P=0·01 and of –6·2 ms on isovolumic relaxation time (P=0·005), but no effects on left ventricular volumes or ejection fraction. There was a trend towards reduced mortality (one death in the nisoldipine-CC group vs seven in the placebo group, P≥0·07) and the combined end-point of mortality and cardiac events (P0·09). Peripheral oedema occurred in 49 patients assigned to nisoldipine-CC and two assigned to placebo (P≥0·001). There were no differences in non-cardiac events.

Conclusions Nisoldipine-CC did not improve exercise time but increased time to 1 mm ST deviation, and improved diastolic left ventricular function. It is safe and well tolerated in post-infarction patients with impaired left ventricular function.

Key Words: Calcium antagonist • post-MI • bicycle ergometry • Doppler echocardiography


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