Clinical cardiology
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Clinical cardiology · Sep 2012
Randomized Controlled TrialCatheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial.
Hypertension represents a significant global public health concern, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. The opportunity to influence clinical outcomes through hypertension management is therefore paramount. Despite adherence to multiple available medical therapies, a significant proportion of patients have persistent blood pressure elevation, a condition termed resistant hypertension. ⋯ The SYMPLICITY HTN-3 Trial is a pivotal study designed as a prospective, randomized, masked procedure, single-blind trial evaluating the safety and effectiveness of catheter-based bilateral renal denervation for the treatment of uncontrolled hypertension despite compliance with at least 3 antihypertensive medications of different classes (at least one of which is a diuretic) at maximal tolerable doses. The primary effectiveness endpoint is measured as the change in office-based systolic blood pressure from baseline to 6 months. This manuscript describes the design and methodology of a regulatory trial of selective renal denervation for the treatment of hypertension among patients who have failed pharmacologic therapy.
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Clinical cardiology · Jan 2012
Randomized Controlled TrialDesign and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy.
Lowering low-density lipoprotein cholesterol (LDL-C) is a cornerstone for the prevention of atherosclerotic heart disease, improving clinical outcomes and reducing vascular mortality in patients with hypercholesterolemia. The clinical benefits of LDL-C reduction appear to extend even to patients starting with LDL-C as low as 60-80 mg/dL prior to initiating therapy. Statins are the first-line agents for treating hypercholesterolemia and are effective in reducing LDL-C, but many patients are unable to achieve their optimal lipid targets despite intensive statin therapy. ⋯ Conversely, inhibition of PCSK9 can profoundly decrease circulating LDL-C, and thus is an attractive new target for LDL-C-lowering therapy. AMG 145 is a fully human monoclonal immunoglobulin G2 antibody that binds specifically to human PCSK9 and inhibits its interaction with the low-density lipoprotein receptor. In this manuscript, we describe the rationale and design of LDL-C Assessment with PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-Thrombolysis In Myocardial Infarction 57 (LAPLACE-TIMI 57; NCT01380730), a 12-week, randomized, double-blind, dose-ranging, placebo-controlled study designed to assess the safety and efficacy of AMG 145 when added to statin therapy in patients with hypercholesterolemia.
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Clinical cardiology · Jul 2011
Randomized Controlled TrialRanolazine for the treatment of heart failure with preserved ejection fraction: background, aims, and design of the RALI-DHF study.
Heart failure with preserved ejection fraction (HFpEF), formerly referred to as diastolic heart failure (DHF), accounts for >50% of all HF patients. So far, there has been no specific treatment for impaired left ventricular (LV) relaxation. Data from in vitro and animal studies indicate that ranolazine improves diastolic function by inhibiting the late sodium current. ⋯ The RALI-DHF study is designed as a translational study to bridge the gap between basic science and therapeutics and to determine if ranolazine, compared with placebo, will be more effective in improving diastolic function in patients with HFpEF.
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Clinical cardiology · Feb 2011
Randomized Controlled TrialThe effects of statin monotherapy and low-dose statin/ezetimibe on lipoprotein-associated phospholipase A₂.
Many of the pleiotropic effects of statins remain to be elucidated. ⋯ Atorvastatin monotherapy was stronger at reducing plasma Lp-PLA₂ than the low-dose atorvastatin/ezetimibe combination after equivalent LDL-C lowering. This result may provide evidence of potential statin effects beyond the lowering of LDL-C.
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Clinical cardiology · Sep 2010
Randomized Controlled TrialDiagnostic value of poor R-wave progression in electrocardiograms for diabetic cardiomyopathy in type 2 diabetic patients.
Diabetic cardiomyopathy (DCMP) is a common complication of diabetes and is associated with increased mortality. It has been suggested that a poor R-wave progression in a resting electrocardiogram (ECG) could be a sign of cardiomyopathy. ⋯ LV diastolic dysfunction is more frequently observed in diabetic patients with poor R-wave progression in ECG, which may be an early sign of LV dysfunction and DCMP in diabetics.