The American journal of cardiology
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Randomized Controlled Trial Clinical Trial
Rationale, design, and organization of the Metoprolol CR/XL Randomized Intervention Trial in Heart Failure (MERIT-HF). The International Steering Committee.
Metoprolol is a cardioselective beta blocker that has been shown to improve left ventricular function and symptoms of congestive heart failure (CHF) and also to decrease the number of hospitalizations due to CHF. However, the effects of metoprolol on mortality in patients with CHF have yet to be determined. Accordingly, the Metoprolol CR/XL Randomized Intervention Trial in Heart Failure (MERIT-HF) has been designed to investigate the effect of once-daily dosing of metoprolol succinate controlled release/extended release (CR/XL) when added to standard therapy in patients with CHF. ⋯ The mean follow-up is estimated to be 2.4 years. The study data will be analyzed on an intention-to-treat basis. An Independent Safety Committee will monitor the safety aspects of the trial, and an Independent Endpoint Committee will classify all endpoints.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Approach to cost-effectiveness assessment in the MADIT trial. Multicenter Automatic Defibrillator Implantation Trial.
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Randomized Controlled Trial Clinical Trial
Effects of short-term treatment of nicorandil on exercise-induced myocardial ischemia and abnormal cardiac autonomic activity in microvascular angina.
The underlying mechanisms of myocardial ischemia in microvascular angina may include endothelial dysfunction, abnormal smooth muscle tone, and abnormal autonomic control of coronary microvasculatures. This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the effect of nicorandil (a nitrate-potassium channel opener) therapy on exercise-induced myocardial ischemia and cardiac autonomic activity in 13 patients with microvascular angina. After a 2-week placebo run-in period, patients were randomly assigned to the first 2-week treatment with nicorandil 5 mg tid or placebo, then crossed over to the second 2-week treatment after a 2-week washout period. ⋯ Nicorandil treatment did not change the altered heart rate variability in either time domain or spectral analysis. Systemic hemodynamics were also unchanged with nicorandil treatment. Thus, 2-week oral nicorandil therapy moderately improved exercise-induced myocardial ischemia without modifying the already altered cardiac autonomic activity, suggesting that nicorandil might have a direct vasodilatory effect on coronary microvasculatures in patients with microvascular angina.
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Review Randomized Controlled Trial Comparative Study Clinical Trial
Patency trials with reteplase (r-PA): what do they tell us?
Thrombolytic therapy has been shown to reduce mortality and morbidity after acute myocardial infarction. Therapeutic benefit seems to be directly correlated with completeness of reperfusion (Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow) of the infarct-related coronary artery, as well as the timeliness of reperfusion. To determine which regimen of reteplase (r-PA), a deletion mutant of wild-type tissue plasminogen activator (t-PA), is most effective for clinical thrombolysis, several reteplase regimens were compared with the most successful standard regimens of recombinant t-PA (alteplase) in 2 large-scale, randomized studies. ⋯ Reteplase and alteplase did not differ significantly with regard to the occurrence of severe bleeding (12.4% vs 9.7%, respectively) or hemorrhagic stroke (1.2% vs 1.9%, respectively). The results of these trials show that reteplase, given as a 10 + 10 U double bolus, achieves significantly higher rates of early reperfusion of the infarct-related coronary artery and is associated with significantly fewer acute coronary interventions when compared with front-loaded alteplase. The benefits of reteplase are achieved without any apparent increased risk of complications.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Conversion of recent-onset Atrial Fibrillation by a single oral dose of Pilsicainide (Pilsicainide Suppression Trial on atrial fibrillation). The PSTAF Investigators.
The efficacy and safety of a single oral dose of 150-mg pilsicainide, a new class Ic antiarrhythmic drug, in converting recent-onset atrial fibrillation to sinus rhythm were evaluated in 75 patients (51 men, 24 women; age 23 to 74 years). Conversion to sinus rhythm was achieved within 90 minutes in 45% of patients given pilsicainide and in 8.6% of those on placebo (p < 0.01), with no major adverse effects.