The American journal of cardiology
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of omapatrilat on hemodynamics and safety in patients with heart failure.
Omapatrilat, a novel vasopeptidase inhibitor, is a highly potent and selective inhibitor of neutral endopeptidase and angiotensin-converting enzyme; its therapeutic potential is being investigated for treatment of hypertension and heart failure. In the present study, the safety, tolerability, and hemodynamic effects of single oral doses of omapatrilat (1 to 50 mg) are compared with placebo in patients with heart failure. Patients with heart failure (New York Heart Association functional class II to IV) and a resting left ventricular ejection fraction < or = 40% were enrolled in a double-blind, placebo-controlled, sequential-panel study of single doses of omapatrilat of 1, 2.5, 5, 10, 25, or 50 mg, followed by hemodynamic assessment for 24 hours. ⋯ Additionally, by 2 hours after dosing with omapatrilat 25 and 50 mg, a trend in peak increases from baseline in plasma atrial natriuretic peptide (twofold) and cyclic guanosine monophosphate (nearly twofold) was observed. Moreover, omapatrilat was well tolerated. Thus, omapatrilat administered orally to patients with heart failure was safe and well tolerated and resulted in improved hemodynamic performance.
-
Rapid, efficient, and accurate evaluation of chest pain patients in the emergency department optimizes patient care from public health, economic, and liability perspectives. To evaluate the performance of an accelerated critical pathway for patients with suspected coronary ischemia that utilizes clinical history, electrocardiographic findings, and triple cardiac marker testing (cardiac troponin I [cTnI], myoglobin, and creatine kinase-MB [CK-MB]), we performed an observational study of a chest pain critical pathway in the setting of a large Emergency Department at the Veterans Affairs Medical Center in 1,285 consecutive patients with signs and symptoms of cardiac ischemia. The accelerated critical pathway for chest pain evaluation was analyzed for: (1) accuracy in triaging of patients within 90 minutes of presentation, (2) sensitivity, specificity, positive predictive value, and negative predictive value of cTnI, myoglobin, and CK-MB in diagnosing acute myocardial infarction (MI) within 90 minutes, and (3) impact on Coronary Care Unit (CCU) admissions. ⋯ CCU admissions decreased by 40%. Ninety percent of patients with negative cardiac markers and a negative electrocardiogram at 90 minutes were discharged home with 1 patient returning with an MI (0.2%) within the next 30 days. Thus, a simple, inexpensive, yet aggressive critical pathway that utilizes high-risk features from clinical history, electrocardiographic changes, and rapid point-of-care testing of 3 cardiac markers allows for accurate triaging of chest pain patients within 90 minutes of presenting to the emergency department.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia.
Rosuvastatin is a new, synthetic, orally active statin, with marked low-density lipoprotein (LDL) cholesterol-lowering activity. We conducted 2 dose-ranging studies. In the first study, after a 6-week dietary run-in, 142 moderately hypercholesterolemic patients were randomized equally to receive double-blind placebo or rosuvastatin 1, 2.5, 5, 10, 20, or 40 mg or open-label atorvastatin 10 or 80 mg once daily for 6 weeks; in the second study, conducted to extend the rosuvastatin dose range, 64 patients were randomized to double-blind, once-daily placebo or rosuvastatin 40 or 80 mg (1:1:2 ratio) for 6 weeks. ⋯ Adverse events were similar across placebo and active treatments. No significant increases in alanine aminotransferase or creatine kinase were seen in any patient. Over 6 weeks, rosuvastatin produced large, rapid, dose-dependent LDL cholesterol reductions and was well tolerated in hypercholesterolemic patients.
-
Comparative Study Clinical Trial Controlled Clinical Trial
Value of quantitative analysis of mitral regurgitation jet eccentricity by color flow Doppler for identification of flail leaflet.
Early surgical intervention improves the outcome of patients with mitral regurgitation (MR) secondary to flail leaflet. Current criteria for the diagnosis of flail leaflet require a detailed definition of mitral valve anatomy, which is often challenging by transthoracic echocardiography (TTE) and, occasionally, even by transesophageal echocardiography (TEE). We studied 57 patients (mean age 63 +/- 15 years) with anatomically confirmed flail mitral leaflet and a control group of 57 patients (mean age 68 +/-14 years) with at least moderate MR but no flail leaflet. ⋯ Based on receiver- operating characteristic analysis, the optimal cutoff jet angle value for diagnosing flail mitral leaflet was 45 degrees with TTE (sensitivity 88%, specificity 88%), and 47 degrees by TEE (sensitivity 88%, specificity 88%). MR jet angles < or =45 degrees were also correctly identified by visual assessment of TTE images in >90% of cases, with good interobserver agreement (k = 0.76). Thus, quantitative analysis of MR jet eccentricity by color flow Doppler is highly sensitive and specific for diagnosing flail mitral leaflet.