ACUTE HEMODYNAMIC AND LONG-TERM CLINICAL EFFECTS OF ISRADIPINE IN PATIENTS WITH CORONARY-ARTERY DISEASE AND CHRONIC HEART-FAILURE - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

To assess the acute hemodynamic and long-term clinical effects of isra dipine, a calcium antagonist of the dihydropyridine class, we performe d a double-blind, placebo-controlled parallel study in 19 patients wit h coronary artery disease (CAD) and stable chronic heart failure (CHF) . Their mean age was 56 +/- 5 years, and left ventricular ejection fra ction (LVEF) was 0.18 +/- 0.05. Patients were treated with diuretics a nd digoxin only. All were clinically stable and in sinus rhythm. The a cute hemodynamic study showed that (intravenous) isradipine increased cardiac index (+36%) and stroke volume index (+30%) (both P < 0.001), while systemic vascular resistance (-33%) and mean arterial pressure ( -10%) decreased (both P < 0.005). Filling pressures and heart rate wer e not affected. Of the 19 patients, 17 completed the 12 week study; 2 patients on placebo (1 death, 1 side-effects), but no patient on israd ipine (5 mg 3 times daily) dropped out. After 12 weeks, peak oxygen co nsumption (VO2), LVEF, echocardiographic indices, and other clinical p arameters were unaffected by treatment. Repeat invasive hemodynamic me asurements showed that the initial improvement by isradipine was not p resent anymore. In conclusion, despite a beneficial acute hemodynamic effect, isradipine has no favorable clinical influence during prolonge d treatment in patients with mild to moderate CHF.