Abstract:
BACKGROUND:Although quantification of the impact of treatment on survival remains the cornerstone of clinical research, the assessment of a broader range of disease outcomes is growing increasingly important. This manuscript provides an overview of the considerations made regarding quantification of a range of clinical and economic outcomes in the EPHESUS (EPlerenone's neuroHormonal Efficacy and SUrvival Study) study, a 6200-patient, randomized, controlled trial of aldosterone blockade in patients with heart failure as a complication of acute myocardial infarction. METHODS AND RESULTS:Relevant clinical outcomes include disease progression (mortality, hospitalization), health status (symptoms, functioning, and quality of life), and costs. The primary hypothesis for the quality of life component of EPHESUS is that eplerenone will improve health status as defined by the Kansas City Cardiomyopathy Questionnaire summary score. In addition to the Kansas City Cardiomyopathy Questionnaire, the Short Form-12, the EuroQOL, the Medical Outcomes Study-Depression Scale and an Anxiety measure will be collected throughout the trial. Health care resource utilization including hospitalizations, emergency room visits, outpatient procedures and tests, and medications will also be collected. Analyses will estimate and describe the effect of aldosterone blockade on costs over time. If both the clinical effect and costs are greater for patients receiving aldosterone blockade, then eplerenone's cost-effectiveness will be estimated. CONCLUSION:The EPHESUS trial has been designed to quantify a wide range of clinical outcomes. This broad range of data will allow a comprehensive assessment of the potential benefits of aldosterone blockade on patient health status and costs.
journal_name
Am Heart Jjournal_title
American heart journalauthors
Spertus JA,Tooley J,Jones P,Poston C,Mahoney E,Deedwania P,Hurley S,Pitt B,Weintraub WSdoi
10.1067/mhj.2002.120775subject
Has Abstractpub_date
2002-04-01 00:00:00pages
636-42issue
4eissn
0002-8703issn
1097-6744pii
S0002870302805531journal_volume
143pub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Bleeding and blood transfusion are associated with increased morbidity and mortality among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS); however, the economic consequences of these complications are not well defined. We sought to determine the relationship between bleeding, bloo...
journal_title:American heart journal
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.ahj.2007.10.014
更新日期:2008-02-01 00:00:00
abstract::Plasma levels of endothelin-1 are elevated in patients with chronic heart failure; however, it is unknown whether changes in plasma endothelin-1 levels accurately reflect clinical response to therapy in these patients. To determine this, we measured plasma endothelin-1 in addition to functional, hemodynamic, and other...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0002-8703(96)90363-4
更新日期:1996-02-01 00:00:00
abstract::Intracoronary streptokinase (SK) was administered to 11 patients with evolving acute transmural myocardial infarction 5.5 +/- 0.4 hours from the onset of symptoms. Ten patients (91%) had total coronary occlusion, and one had subocclusion of the vessel corresponding to the ECG site of infarction. Intracoronary nitrogly...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(81)90646-3
更新日期:1981-12-01 00:00:00
abstract:BACKGROUND:Recently revised American College of Cardiology/American Heart Association guidelines for exercise electrocardiography (ExECG) have suggested that ExECG scores be used to assist in management decisions in patients with suspected coronary artery disease (CAD). METHODS:We used 442 women who underwent both ExE...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1067/mhj.2002.125835
更新日期:2002-11-01 00:00:00
abstract::Asymptomatic atrial fibrillation (AF) is common and may have the same prognostic implications as symptomatic AF. Among patients receiving dual-chamber pacemakers, it is now possible to quantify asymptomatic AF accurately. Most of these episodes are of short duration, often lasting only seconds to minutes and are calle...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2006.02.016
更新日期:2006-09-01 00:00:00
abstract::Angioscopy has been shown to provide more detailed information on lesion morphology before and after interventional procedures than angiography. Therefore to evaluate the effects of laser angioplasty, angioscopy was performed in five patients with peripheral or coronary vascular disease who underwent excimer laser ang...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(92)90058-4
更新日期:1992-12-01 00:00:00
abstract:BACKGROUND:The American Heart Association recommends women with congenital heart defects (CHD) receive contraceptive counseling early in their reproductive years, but little is known about contraceptive method use among women with CHD. We describe recent female sterilization and reversible prescription contraceptive me...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ahj.2020.01.008
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:Dobutamine and exercise echocardiography are accepted as tests of comparable efficacy for the diagnosis of coronary artery disease. Although dobutamine has been classified as "exercise simulating," the mechanisms of ischemia with dobutamine and exercise have not been well studied. This study sought to compar...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(98)70183-8
更新日期:1998-07-01 00:00:00
abstract::A population of 2955 patients admitted to the hospital with acute myocardial infarction (AMI) was followed for 1 year after AMI or until death. Smokers as compared to nonsmokers were over 10 years younger (p less than 0.001) and had a lower prevalence of hypertension (p less than 0.01), congestive heart failure (p les...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(85)90071-7
更新日期:1985-09-01 00:00:00
abstract::To evaluate whether the identification of the different types of relations between premature ventricular contractions (PVCs) and the preceding sinus cycle length is capable of predicting the effect of beta-blockers on the PVCs themselves, 55 patients (43 men, 12 women, mean age 52.6 +/- 15.6 years) with different card...
journal_title:American heart journal
pub_type: 临床试验,杂志文章
doi:10.1016/s0002-8703(96)90529-3
更新日期:1996-03-01 00:00:00
abstract:BACKGROUND:Symptoms of anxiety are associated with increased risk of coronary artery disease and potentially poor prognosis among patients with existing coronary artery disease, but whether symptoms of anxiety influence atherosclerotic progression among such patients is uncertain. Accordingly, we evaluated the hypothes...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2009.08.019
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:Randomized trials have indicated that primary coronary angioplasty performed in patients admitted directly to highly-experienced angioplasty centers offers certain advantages over intravenous fibrinolytic therapy. However, the large majority of patients with acute myocardial infarction are submitted to hospi...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/S0002-8703(03)00316-8
更新日期:2003-08-01 00:00:00
abstract::The present study refers to six patients in whom an A-V reciprocal rhythm could be documented; in four cases it took the form of sustained tachycardia. None of the patients showed any ECG feature of ventricular pre-excitation (PR interval of more than 0.12 sec. and normal QRS configuration). The extrastimulus method s...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(76)80427-9
更新日期:1976-01-01 00:00:00
abstract::A total of 127 patients with chronic heart failure referred to our exercise laboratory were studied retrospectively to identify parameters predictive of prognosis. Patients were followed for a mean of 14.6 months. The group as a whole had severe ventricular dysfunction with a median ejection fraction of 17% and a medi...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(92)90656-g
更新日期:1992-02-01 00:00:00
abstract::Doxazosin, a selective alpha 1-inhibitor, was assessed for antihypertensive efficacy, effect on lipid parameters, and safety profile in 21 hypertensive patients with noninsulin-dependent diabetes mellitus. The study involved a 2- to 4-week baseline period, a 10-week period in which patients received doxazosin, 1 to 8 ...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(88)90229-3
更新日期:1988-12-01 00:00:00
abstract:BACKGROUND:Older adults presenting with acute myocardial infarction (MI) often have multivessel coronary artery disease amenable to percutaneous coronary intervention (PCI), yet the risks of multivessel intervention may outweigh potential benefits in these patients. We sought to determine if nonculprit intervention dur...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.ahj.2015.10.017
更新日期:2016-02-01 00:00:00
abstract::Myocardial ischemia, electrolyte changes, and fluctuations in autonomic tone may play an important role in the presentation of malignant ventricular arrhythmias. beta-Adrenoceptor blocking agents have been shown to decrease the incidence of ventricular fibrillation and sudden cardiac death in patients with coronary ar...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(94)90015-9
更新日期:1994-07-01 00:00:00
abstract::Detection of mild hypertension by a small number of casual blood pressures may be inaccurate for the determination of average blood pressure. Nonetheless, casual pressures remain the basis for the diagnosis and treatment of hypertensive patients. We compared casual and noninvasive ambulatory blood pressure monitoring ...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(88)90180-9
更新日期:1988-10-01 00:00:00
abstract::We studied the possibility that a mitral regurgitant Doppler signal area on a two-dimensional color Doppler echocardiogram can reflect changes in mitral regurgitant volume in 24 patients with several types of mitral regurgitation. In 20 patients, mitral regurgitant Doppler signal areas were clear enough to measure. In...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(87)90502-3
更新日期:1987-08-01 00:00:00
abstract:BACKGROUND:Beta-endorphin has been reported to play a role in the mechanism of silent myocardial ischemia. OBJECTIVES:Plasma beta-endorphin levels during coronary angioplasty-induced silent and symptomatic myocardial ischemia were compared with those during exercise-induced silent ischemia. METHODS AND RESULTS:The st...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(98)70039-0
更新日期:1998-05-01 00:00:00
abstract:BACKGROUND:Recent data indicate that cardiac antibodies play an active role in the pathogenesis of dilated cardiomyopathy (DCM) and may contribute to cardiac dysfunction in patients with DCM. The present study investigated the influence of immunoadsorption with subsequent immunoglobulin G substitution (IA/IgG) on cardi...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2010.01.012
更新日期:2010-05-01 00:00:00
abstract::Four hundred and ninety-two patients with coronary artery disease underwent analysis of their electrocardiograms, coronary arteriograms, and ventriculograms. Significant Q-waves were correlated with critical coronary occlusions (greater than or equal 75 per cent obstruction) and ventricular contractility. It was found...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(75)90425-1
更新日期:1975-10-01 00:00:00
abstract::Externally recorded STI were compared with invasively determined EF in 10 normal subjects and 86 patients with various forms of chronic heart disease. From phono-, apex-, and electrocardiograms and carotid pulse tracings, recorded without rigidly controlled conditions (postabsorptive state, fixed time of day, exclusio...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(77)80246-9
更新日期:1977-03-01 00:00:00
abstract::Left ventricular (LV) filling was examined by Doppler and M-mode echocardiography in 24 patients with LV hypertrophy (five with aortic stenosis, six with hypertrophic cardiomyopathy, and 13 with LV hypertrophy secondary to systemic hypertension) and in 18 normal subjects. Patients with LV hypertrophy had significantly...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(87)90657-0
更新日期:1987-06-01 00:00:00
abstract:BACKGROUND:The LaFarge equation is the most commonly used equation to estimate oxygen consumption (Vo(2)) in patients of all ages with congenital heart disease, although it was generated in patients older than 3 years. We sought to determine the validity of the LaFarge equation in estimating Vo(2) in children younger t...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2010.04.003
更新日期:2010-07-01 00:00:00
abstract::Previous studies have suggested that the contractility of isolated heart muscle removed from rabbits made hypercholesterolemic is decreased. As part of a study evaluating the effects of high-lipid diets on aortic atherosclerosis, we evaluated the contractility of perfused rabbit hearts. Six rabbits were placed on a hi...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(83)90049-2
更新日期:1983-12-01 00:00:00
abstract:BACKGROUND:After ST-elevation myocardial infarction (STEMI), microvascular obstruction (MVO) can be assessed using semiquantitative angiographic "blush" scores subject to interoperator variability. Quantitative Blush Evaluator (QuBE) is a free computer-calculated algorithm that evaluates myocardial blush on a continuou...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2011.04.014
更新日期:2011-08-01 00:00:00
abstract::We retrospectively contrasted the medical outcome of patients removed from the heart transplant consideration list because of clinical improvement with that of transplant recipients. Of 60 patients awaiting transplantation, 18 were removed from the list (group A), and 42 required transplant or died (group B). Group A ...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(96)90462-7
更新日期:1996-12-01 00:00:00
abstract:BACKGROUND:Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverabilit...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.ahj.2012.02.001
更新日期:2012-04-01 00:00:00
abstract:BACKGROUND:Accurate, reproducible, noninvasive determination of left ventricular (LV) volumes and ejection fraction (EF) is important for clinical assessment, risk stratification, selection of therapy, and serial monitoring of patients with cardiovascular disease. Three-dimensional echocardiography (3DE) approaches hav...
journal_title:American heart journal
pub_type: 临床试验,杂志文章
doi:10.1067/mhj.2000.108513
更新日期:2000-09-01 00:00:00