The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Clinical Trial
Intravenous diltiazem for the treatment of patients with atrial fibrillation or flutter and moderate to severe congestive heart failure.
The objective of this multicenter, randomized, double-blind, placebo-controlled study was to determine the safety and efficacy of intravenous diltiazem in the treatment of 37 patients with rapid (ventricular rate, mean +/- SD 142 +/- 17 beats/min) atrial fibrillation or flutter and moderate to severe congestive heart failure (ejection fraction, mean +/- SD 36 +/- 14%; New York Heart Association class III [23 patients], class IV [14 patients]). During the double-blind portion of the study, patients received either intravenous diltiazem, 0.25 mg/kg over 2 minutes, or placebo followed 15 minutes later by diltiazem or placebo, 0.35 mg/kg over 2 minutes, if the first dose was tolerated but ineffective. Placebo nonresponders were given open-label intravenous diltiazem in a similar fashion as in the double-blind portion of the study. ⋯ All 15 patients (13 with 0.25 mg/kg and 2 with an additional 0.35 mg/kg) who received placebo during the double-blind period had a therapeutic response to diltiazem during open-label therapy. Overall, 36 of 37 patients (97%) had a therapeutic response to intravenous diltiazem. Heart rate response to diltiazem after the 2-minute bolus infusions consisted of a > or = 20% decrease in heart rate from baseline in 36 patients; in addition, 17 patients also had heart rates decreased to < 100 beats/min, whereas no patient had conversion to sinus rhythm.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Comparative Study Clinical Trial
Hemodynamics of volume loading compared with dobutamine in severe right ventricular infarction.
To compare the hemodynamic effect of volume loading with that of dobutamine infusion in severe ischemic right ventricular (RV) dysfunction, 11 patients with inferior and RV infarction complicated by low cardiac output syndrome and important hemodynamic derangement (systolic blood pressure < 100 mm Hg, cardiac index < 2.0 liters/min/m2, right atrial pressure > 10 mm Hg) were prospectively studied within 48 hours of symptom onset. After right heart catheterization, volume loading (mean 400 ml saline solution) and dobutamine infusion (5 and 10 micrograms/kg/min over 10 minutes) were performed according to a randomized, crossover design. ⋯ Dobutamine (5 micrograms/kg/min) increased cardiac index (from 1.5 +/- 0.3 to 1.9 +/- 0.5 liters/min/m2, p < 0.05), incrementing both heart rate (from 61 +/- 12 to 70 +/- 13 beats/min, p < 0.05) and stroke volume index (from 25 +/- 6 to 27 +/- 5 ml/beat/m2, p < 0.05), as well as right (from 1.4 +/- 1.6 to 2.3 +/- 2.2 g.m/m2, p < 0.05) and left (from 21 +/- 7 to 27 +/- 10 g.m/m2, p < 0.05) stroke work indexes; right and left ventricular filling pressures did not decrease. Dobutamine (10 micrograms/kg/min) significantly improved myocardial performance.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Clinical Trial
Clinical predictors of implantable cardioverter-defibrillator shocks (results of the CASCADE trial). Cardiac Arrest in Seattle, Conventional versus Amiodarone Drug Evaluation.
The Cardiac Arrest in Seattle, Conventional Versus Amiodarone Drug Evaluation (CASCADE) study evaluated antiarrhythmic drug therapy in high-risk survivors of out-of-hospital ventricular fibrillation. Antiarrhythmic drug therapy for 228 patients was randomized to amiodarone or conventional antiarrhythmic drugs. Additional therapy with an implantable cardioverter-defibrillator was provided to 105 of these patients. ⋯ The independent clinical predictors of shocks were low ejection fraction (p = 0.002), female gender (p = 0.007) and conventional antiarrhythmic drug therapy (p = 0.015). The only independent predictor of a shock associated with syncope was conventional antiarrhythmic drug therapy (p = 0.035). Patients treated with amiodarone receive fewer shocks than patients treated with conventional drug therapy.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of extended-release isosorbide mononitrate for stable effort angina pectoris.
The efficacy and safety of extended-release isosorbide mononitrate tablets were evaluated in patients with stable effort angina. In a double-blind study, 313 patients with stable effort-induced angina were randomized to receive placebo or extended-release isosorbide mononitrate: 30, 60, 120 or 240 mg once daily in the morning. Serial exercise testing was performed using the standard Bruce treadmill protocol on days 1, 7, 14, 28 and 42 immediately before morning drug administration, and 4 and 12 hours after administration. ⋯ Thus, there was neither significant activity nor demonstrable rebound of effort-induced angina (zero-hour effect) at the end of the dosing interval. Transient headache was the most prevalent adverse experience. Extended-release isosorbide mononitrate (120 and 240 mg administered orally once daily) significantly prolonged exercise time to development of moderate effort-induced angina 4 and 12 hours after dosing during long-term therapy, without development of nitrate tolerance.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Clinical Trial
Rehospitalization in surviving patients of out-of-hospital ventricular fibrillation (the CASCADE Study). Cardiac Arrest in Seattle: Conventional Amiodarone Drug Evaluation.
Surviving patients of out-of-hospital ventricular fibrillation (VF) often need rehospitalization after initial hospital discharge, but little is known regarding the frequency of or reasons for rehospitalization. Rehospitalization was examined in 224 patients enrolled in the Cardiac Arrest in Seattle: Conventional Amiodarone Drug Evaluation (CASCADE) study, a randomized clinical trial comparing amiodarone with other antiarrhythmic drug therapy in survivors of out-of-hospital VF. The annual rate of rehospitalization was 79/100 patients/year; 168 of 224 patients (75%) were hospitalized at least once before censoring or cardiac mortality. ⋯ However, length of stay for the first rehospitalization was shorter for patients with automatic implantable cardioverter-defibrillators (p = 0.005). More than 50% of patients were rehospitalized in the first year after enrollment; 65% with ejection fractions < or = 0.3 were rehospitalized in the first year. Rehospitalization was a frequent occurrence for surviving patients of out-of-hospital VF, particularly in those with low ejection fractions.