American heart journal
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American heart journal · Aug 2012
Randomized Controlled TrialThe rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.
Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. ⋯ Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013.
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American heart journal · Jul 2012
Randomized Controlled Trial Multicenter StudyCardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities.
Comprehensive safety evaluation of new drugs for noncardiac indications is needed in the area of cardiovascular (CV) outcomes, particularly in populations with high CV risk such as gout. Febuxostat is a potent nonpurine selective inhibitor of xanthine oxidase approved for the treatment of gout. Long-term CV safety of febuxostat is being established in a randomized, allopurinol-controlled clinical study in patients with gout who have increased CV risk using an analytical approach that provides 90% power to meet a noninferiority margin of 1.3 for the hazard ratio (HR) (febuxostat relative to allopurinol). ⋯ Interim analyses will be conducted when approximately 25%, 50%, and 75% of events have occurred. At each analysis, if the upper 1-sided confidence limit of the HR is <1.3, the study will be stopped, and the noninferiority of febuxostat relative to allopurinol with regard to CV risk will be declared. The CARES trial will define the CV safety profile of febuxostat and allopurinol in gout patients at high risk for CV events.
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American heart journal · Jun 2012
Randomized Controlled TrialA pilot randomized study of ranolazine for reduction of myocardial damage during elective percutaneous coronary intervention.
Ranolazine is a new antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia, thus potentially limiting myocardial ischemia. It remains unknown, however, if the drug can play a role in the pathophysiology of periprocedural myocardial infarction. The aim of this study was to verify in a randomized study if pretreatment with ranolazine before percutaneous coronary intervention (PCI) has any protective effect on periprocedural myocardial damage. ⋯ Pretreatment with ranolazine 1,000 mg twice daily for 7 days significantly reduced procedural myocardial injury in elective PCI.
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American heart journal · Jun 2012
Randomized Controlled TrialRacial differences in hospice use and patterns of care after enrollment in hospice among Medicare beneficiaries with heart failure.
We examined racial differences in patterns of care and resource use among Medicare beneficiaries with heart failure after enrollment in hospice. ⋯ Rates of hospice use have increased over time for both white and nonwhite patients. Nonwhite patients were less likely than white patients to enroll in hospice and had higher resource use after electing hospice care, regardless of disenrollment status.
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American heart journal · Jun 2012
Randomized Controlled Trial Multicenter StudyIntraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial.
In current guidelines, intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock. ⋯ The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction.