Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.00264.X
D. Sica
Controlled clinical trials in cardiovascular disease remain the cornerstone of field-specific therapeutic advances. Since the introduction of the concept of controlled clinical trials, there has been considerable fine-tuning of the design, conduct, and analysis of such studies. A growing awareness of ethical issues emerging from such trials has led to increased public and investigator scrutiny and the routine requirement for both interim data analysis and full conflict-of-interest disclosure. A benefit of such interim analyses is that either an entire clinical trial or a specific treatment limb can be stopped if the observed findings warrant early termination. For example, highly positive findings, as were noted in the HOPE Study (Heart Outcomes Prevention Evaluation), led to its closure after 4.5 years of treatment, which was 1 year earlier than anticipated. Also, the doxazosin treatment limb of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) and the amlodipine treatment limb of AASK (African American Study of Kidney Disease and Hypertension) were stopped early, because of negative findings in one of their treatment limbs. Finally, economic considerations can enter into the decision to close a study early, as was the case in the CONVINCE (Controlled-Onset Verapamil Investigation of Cardiovascular Endpoints) trial. Most such decisions rely heavily on information obtained from independent data and safety monitoring boards. Such boards ensure patient safety by providing an unbiased, ongoing review of data, which would otherwise be unavailable until a study's completion. Early termination of a clinical trial can have important clinical and economic implications and, in particular, can substantially redirect the pattern of clinical practice. (c)2001 CHF, Inc.
{"title":"Pharmacotherapy in congestive heart failure. Prematurely terminated clinical trials and their application to cardiovascular medicine.","authors":"D. Sica","doi":"10.1111/J.1527-5299.2001.00264.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00264.X","url":null,"abstract":"Controlled clinical trials in cardiovascular disease remain the cornerstone of field-specific therapeutic advances. Since the introduction of the concept of controlled clinical trials, there has been considerable fine-tuning of the design, conduct, and analysis of such studies. A growing awareness of ethical issues emerging from such trials has led to increased public and investigator scrutiny and the routine requirement for both interim data analysis and full conflict-of-interest disclosure. A benefit of such interim analyses is that either an entire clinical trial or a specific treatment limb can be stopped if the observed findings warrant early termination. For example, highly positive findings, as were noted in the HOPE Study (Heart Outcomes Prevention Evaluation), led to its closure after 4.5 years of treatment, which was 1 year earlier than anticipated. Also, the doxazosin treatment limb of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) and the amlodipine treatment limb of AASK (African American Study of Kidney Disease and Hypertension) were stopped early, because of negative findings in one of their treatment limbs. Finally, economic considerations can enter into the decision to close a study early, as was the case in the CONVINCE (Controlled-Onset Verapamil Investigation of Cardiovascular Endpoints) trial. Most such decisions rely heavily on information obtained from independent data and safety monitoring boards. Such boards ensure patient safety by providing an unbiased, ongoing review of data, which would otherwise be unavailable until a study's completion. Early termination of a clinical trial can have important clinical and economic implications and, in particular, can substantially redirect the pattern of clinical practice. (c)2001 CHF, Inc.","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"116 1","pages":"265-271"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79243096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.00278.X
N. Mikhail, Adel El-Bialy, Jeremy Grosser
Despite the crucial role of calcium in myocardial contractility, hypocalcemia has been rarely reported as a cause of heart failure. In this article, the authors describe a case of severe hypocalcemia caused by idiopathic hypoparathyroidism and worsened by concomitant hypomagnesemia. The patient presented with congestive heart failure that improved dramatically with amelioration of plasma calcium levels. This case and other similar cases in the literature revealed that hypocalcemic heart failure is reversible. Measurement of plasma calcium should be included in the initial work-up of all patients with heart failure, and plasma magnesium must also be checked and corrected if hypocalcemia is demonstrated. (c)2001 CHF, Inc.
{"title":"Severe hypocalcemia: a rare cause of reversible heart failure.","authors":"N. Mikhail, Adel El-Bialy, Jeremy Grosser","doi":"10.1111/J.1527-5299.2001.00278.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00278.X","url":null,"abstract":"Despite the crucial role of calcium in myocardial contractility, hypocalcemia has been rarely reported as a cause of heart failure. In this article, the authors describe a case of severe hypocalcemia caused by idiopathic hypoparathyroidism and worsened by concomitant hypomagnesemia. The patient presented with congestive heart failure that improved dramatically with amelioration of plasma calcium levels. This case and other similar cases in the literature revealed that hypocalcemic heart failure is reversible. Measurement of plasma calcium should be included in the initial work-up of all patients with heart failure, and plasma magnesium must also be checked and corrected if hypocalcemia is demonstrated. (c)2001 CHF, Inc.","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"66 1","pages":"256-258"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73871524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.00260.X
M. Cicoira, A. Rossi, G. Golia, G. Gasparini, M. Anselmi, P. Zardini
This study was conducted to assess the accuracy of the estimated mitral regurgitant volume using both the left atrial filling volume and the systolic component of pulmonary vein flow expressed as the percent of its total. Since mitral regurgitation fills the left atrial chamber, the variation in atrial volume during ventricular systole has been proposed as a means to evaluate the severity of regurgitation. Although the correlation with invasive grading of mitral regurgitation is good, there is an unacceptable overlap among grades caused by the absence of information concerning pulmonary vein flow, which enters the left atrium while regurgitation occurs. The Doppler regurgitant volume, or Dp-RVol (mitral stroke volume minus aortic stroke volume) was quantified in 74 patients with any degree and etiology of mitral regurgitation. Atrial volumes were measured from the four-chamber apical view (biplane area-length method). The systolic time-velocity integral of pulmonary vein flow was expressed as the percent of the total (PVs%) (systolic-diastolic) time-velocity integral. These parameters were subjected to multivariate analysis and a regression equation was obtained. The equation was subsequently applied to a group of 31 patients without mitral regurgitation, as evaluated by color Doppler or continuous-wave Doppler and to the overall population (105 patients) in order to estimate the mitral regurgitant volume. In 74 patients with mitral regurgitation, the Doppler regurgitant volume was univariately correlated with the left atrial filling volume (r= 0.74; p<0.0001) and the systolic pulmonary vein velocity integral expressed as the percent of the total (r=0.67; p<0.0001). In multiple regression analysis, the combination of atrial filling and the pulmonary vein velocity integral provided the more accurate estimation of the regurgitant volume (R2=0.84; standard error of the estimate [SEE], 13.9 mL; p<0.0001; Dp-RVol equals 7.84+[1.08*left atrial filling volume] 2 [0.839*PVs%]). In 31 patients with no mitral regurgitation detected by color Doppler or continuous wave Doppler the estimated regurgitant volume was 4.3±6.6 mL. In the overall population the estimated regurgitant volume and the Doppler regurgitant volume correlated well with each other (R2=0.85; SEE, 11.5 mL; p<0.0001). The equation was 100% sensitive and 98% specific in detecting a regurgitant volume higher than 55 mL. The combination of the atrial filling volume and the systolic pulmonary vein time-velocity integral expressed as the percent of the total allows reliable estimation of the regurgitant volume in patients with mitral regurgitation. (c)2001 CHF, Inc.
{"title":"Left atrial overload can be used to estimate mitral regurgitant volume.","authors":"M. Cicoira, A. Rossi, G. Golia, G. Gasparini, M. Anselmi, P. Zardini","doi":"10.1111/J.1527-5299.2001.00260.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00260.X","url":null,"abstract":"This study was conducted to assess the accuracy of the estimated mitral regurgitant volume using both the left atrial filling volume and the systolic component of pulmonary vein flow expressed as the percent of its total. Since mitral regurgitation fills the left atrial chamber, the variation in atrial volume during ventricular systole has been proposed as a means to evaluate the severity of regurgitation. Although the correlation with invasive grading of mitral regurgitation is good, there is an unacceptable overlap among grades caused by the absence of information concerning pulmonary vein flow, which enters the left atrium while regurgitation occurs. The Doppler regurgitant volume, or Dp-RVol (mitral stroke volume minus aortic stroke volume) was quantified in 74 patients with any degree and etiology of mitral regurgitation. Atrial volumes were measured from the four-chamber apical view (biplane area-length method). The systolic time-velocity integral of pulmonary vein flow was expressed as the percent of the total (PVs%) (systolic-diastolic) time-velocity integral. These parameters were subjected to multivariate analysis and a regression equation was obtained. The equation was subsequently applied to a group of 31 patients without mitral regurgitation, as evaluated by color Doppler or continuous-wave Doppler and to the overall population (105 patients) in order to estimate the mitral regurgitant volume. In 74 patients with mitral regurgitation, the Doppler regurgitant volume was univariately correlated with the left atrial filling volume (r= 0.74; p<0.0001) and the systolic pulmonary vein velocity integral expressed as the percent of the total (r=0.67; p<0.0001). In multiple regression analysis, the combination of atrial filling and the pulmonary vein velocity integral provided the more accurate estimation of the regurgitant volume (R2=0.84; standard error of the estimate [SEE], 13.9 mL; p<0.0001; Dp-RVol equals 7.84+[1.08*left atrial filling volume] 2 [0.839*PVs%]). In 31 patients with no mitral regurgitation detected by color Doppler or continuous wave Doppler the estimated regurgitant volume was 4.3±6.6 mL. In the overall population the estimated regurgitant volume and the Doppler regurgitant volume correlated well with each other (R2=0.85; SEE, 11.5 mL; p<0.0001). The equation was 100% sensitive and 98% specific in detecting a regurgitant volume higher than 55 mL. The combination of the atrial filling volume and the systolic pulmonary vein time-velocity integral expressed as the percent of the total allows reliable estimation of the regurgitant volume in patients with mitral regurgitation. (c)2001 CHF, Inc.","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"31 1","pages":"259-263"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81152066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.00266.X
A. Grant, P. Uber, M. Park, R. Scott, M. Mehra
The differential diagnosis of dyspnea can be overwhelming in the presence of competing diseases. The recent advent of the peptide marker brain natriuretic peptide has ushered in an era of refined diagnostic capability in heart failure. We present a clinical scenario to illustrate the usefulness of this new biomarker assay in directing appropriate therapy for heart failure. (c)2001 CHF, Inc.
{"title":"Difficult cases in heart failure. Novel diagnostic markers in heart failure: an emerging paradigm shift?","authors":"A. Grant, P. Uber, M. Park, R. Scott, M. Mehra","doi":"10.1111/J.1527-5299.2001.00266.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00266.X","url":null,"abstract":"The differential diagnosis of dyspnea can be overwhelming in the presence of competing diseases. The recent advent of the peptide marker brain natriuretic peptide has ushered in an era of refined diagnostic capability in heart failure. We present a clinical scenario to illustrate the usefulness of this new biomarker assay in directing appropriate therapy for heart failure. (c)2001 CHF, Inc.","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"20 1","pages":"274-276"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77598705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.01216.X
M. Silver
{"title":"Are you ready for another paradigm shift?","authors":"M. Silver","doi":"10.1111/J.1527-5299.2001.01216.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.01216.X","url":null,"abstract":"","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"17 1","pages":"242-243"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80819737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/j.1527-5299.2001.00265.x
D. Tepper
{"title":"Predictors of Isotonic Exercise in Patients With Heart Failure","authors":"D. Tepper","doi":"10.1111/j.1527-5299.2001.00265.x","DOIUrl":"https://doi.org/10.1111/j.1527-5299.2001.00265.x","url":null,"abstract":"","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"461 1","pages":"272-273"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82983749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-09-01DOI: 10.1111/J.1527-5299.2001.00268.X
S. Domenicucci, F. Chiarella, P. Bellone
The contribution of cardiac ultrasound in assessment of the embolic potential of left ventricular thrombi after anterior acute myocardial infarction was verified in a prospective study of serial echocardiograms (mean, 18.9 examinations per patient) obtained over a long-term period (1-72 months; mean, 38±12). The study population comprised 222 patients (162 men; age, 64±11 years) with a first anterior acute myocardial infarction, treated with thrombolysis (group A) or receiving no antithrombolic therapy (group B). Embolism occurred in a total of 12 patients (11 with a left ventricular thrombus; p<0.005) and was more frequent in group B (10 patients; p<0.04). Predictors of embolism were the absence of thrombolysis, detection of a left ventricular thrombus, protrusion or mobility of the thrombus, and morphologic changes in the thrombus over time. Patients in group A had a lower incidence of each of these predictors, and a higher thrombus resolution rate. An appropriate echocardiographic protocol is crucial to assessment of the embolic potential of left ventricular thrombi after anterior acute myocardial infarction and may help to identify candidates for aggressive antithrombotic therapy (c)2001 CHF, Inc.
{"title":"Role of echocardiography in the assessment of left ventricular thrombus embolic potential after anterior acute myocardial infarction.","authors":"S. Domenicucci, F. Chiarella, P. Bellone","doi":"10.1111/J.1527-5299.2001.00268.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00268.X","url":null,"abstract":"The contribution of cardiac ultrasound in assessment of the embolic potential of left ventricular thrombi after anterior acute myocardial infarction was verified in a prospective study of serial echocardiograms (mean, 18.9 examinations per patient) obtained over a long-term period (1-72 months; mean, 38±12). The study population comprised 222 patients (162 men; age, 64±11 years) with a first anterior acute myocardial infarction, treated with thrombolysis (group A) or receiving no antithrombolic therapy (group B). Embolism occurred in a total of 12 patients (11 with a left ventricular thrombus; p<0.005) and was more frequent in group B (10 patients; p<0.04). Predictors of embolism were the absence of thrombolysis, detection of a left ventricular thrombus, protrusion or mobility of the thrombus, and morphologic changes in the thrombus over time. Patients in group A had a lower incidence of each of these predictors, and a higher thrombus resolution rate. An appropriate echocardiographic protocol is crucial to assessment of the embolic potential of left ventricular thrombi after anterior acute myocardial infarction and may help to identify candidates for aggressive antithrombotic therapy (c)2001 CHF, Inc.","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"44 1","pages":"250-255"},"PeriodicalIF":0.0,"publicationDate":"2001-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73570475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2001-07-01DOI: 10.1111/J.1527-5299.2001.00257.X
D. Tepper
{"title":"Frontiers in congestive heart failure: Skeletal muscle mass independently predicts peak oxygen consumption and ventilatory response during exercise in noncachetic patients with chronic heart failure.","authors":"D. Tepper","doi":"10.1111/J.1527-5299.2001.00257.X","DOIUrl":"https://doi.org/10.1111/J.1527-5299.2001.00257.X","url":null,"abstract":"","PeriodicalId":10536,"journal":{"name":"Congestive heart failure","volume":"13 1","pages":"212-213"},"PeriodicalIF":0.0,"publicationDate":"2001-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78802954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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