Cleland, J.G.F.

Unconventional End Points in Cardiovascular Clinical Trials: Should We Be Moving Away From Morbidity and Mortality? (Article)

2009-04-01T00:00:00Z

Background: Mortality and irreversible or major morbid events are the end points conventionally chosen for cardiovascular clinical trials because they are considered to reflect the effects of intervention on the natural history of disease. Other end points are now being considered and implemented because of the recognized limitations associated with using mortality and morbidity as the sole measures of therapeutic efficacy. Methods and Results: This article reflects the discussion and recommendations regarding nontraditional end points for cardiovascular trials generated from a meeting of clinical trial experts convened to discuss this issue. Less common end points that have been used in cardiovascular clinical trials include composite clinical scores integrating measures of quality of life with mortality and morbidity or using the function of vital organs as end points. Appropriate measurement and applications of such end points is controversial. Conclusions: More experience is needed in applying and analyzing results with these nontraditional end points to enable their optimal use in clinical trials in cardiology, but such approaches have the potential to redress many of the conceptual and actual deficiencies inherent in conventional measures of outcome.

Recall of lifestyle advice in patients recently hospitalised with heart failure: A EuroHeart Failure Survey analysis (Article)

2007-11-01T00:00:00Z

Background: There are limited data on recall and implementation of lifestyle advice in patients with heart failure (HF). Aim: To investigate what advice patients with HF recall being given, and whether they report following the advice they remember. Methods and results: 3261 patients with suspected HF participating in the EuroHeart Failure Survey were interviewed by a health professional 12 weeks after hospital discharge. Patients recalled receiving 46% of pre-specified items of advice and 67% reported that they followed these completely. Both recall (53%) and implementation (71%) was best in patients with left ventricular systolic dysfunction (LVSD). In multivariate analysis, younger age, male sex, patient awareness of the condition and patients reporting that they received a clear explanation of the diagnosis by a health professional, all factors associated with having LVSD, were the strongest predictors of recall. Conclusions: Recall of and adherence to advice by patients with HF in this large European cross-sectional survey was disappointing. Responsibility for patient education lies with health professionals who should ensure that patients receive and understand advice, and are able to recall and follow it. A greater awareness of the issues surrounding lifestyle advice and more evidence supporting its value could improve patient care.

Nonpharmacologic Measures and Drug Compliance in Patients with Heart Failure: Data from the EuroHeart Failure Survey (Article)

2007-03-26T00:00:00Z

Advice on lifestyle, diet, vaccination, and therapy are part of the standard management of heart failure (HF). However, there is little information on whether patients with HF recall receiving such recommendations and, if so, whether they report following them. We obtained information on the recall of and adherence to nonpharmacologic advice from patients enrolled in the EuroHeart Failure Survey. This article focuses on 2,331 patients who had a clinical diagnosis of HF during the index admission and attended an interview 12 weeks after discharge. Their mean age was 67 ± 12 years and 38% were women. Patients recalled receiving 4.1 ± 2.7 items of advice with higher rates in Central Europe and the Mediterranean region. Recall of dietary advice (cholesterol or fat intake, 63%; dietary salt, 60%) was higher than for some other interventions (influenza vaccination, 36%; avoidance of nonsteroidal anti-inflammatory drugs, 17%). Among those who recalled the advice, a substantial proportion indicated that they did not follow advice completely (cholesterol and fat intake, 61%; dietary salt, 63%; influenza vaccination, 75%; avoidance of nonsteroidal anti-inflammatory drugs, 80%), although few patients indicated they ignored the advice completely. Patients who recalled >4 items versus ≤4 items of advice were younger and more often received angiotensin-converting enzyme inhibitors (71% vs 62%), β-blockers (51% vs 38%), and spironolactone (25% vs 21%). In conclusion, after hospitalization for HF, many patients do not recall nonpharmacologic advice. In addition, a substantial proportion of those who recall the advice follow it incompletely. Younger age and prescription of appropriate pharmacologic treatment are associated with higher rates of recall and implementation.

International variations in the treatment and co-morbidity of left ventricular systolic dysfunction: Data from the EuroHeart Failure Survey (Article)

2007-03-01T00:00:00Z

Background: Treatment of heart failure (HF) due to left ventricular systolic dysfunction (LVSD) is effective, but many patients are not treated in accordance with guidelines. This may reflect a lack of adequate organisation of care or co-morbidity contra-indicating therapy. Aims: To evaluate the effect of co-morbidities on the prescription of neurohormonal antagonists for HF. Methods and results: The EuroHeart Failure Survey identified 10,701 patients with suspected or confirmed HF during 2000 and 2001, 64% of whom had an imaging test and 3658 had documented LVSD. This last group constitutes the focus of this report. Renal dysfunction was associated with lower prescription of ACE inhibitors at discharge (74% vs. 83%, p < 0.001). Beta-blockers were less often used in patients with respiratory disease (32% vs. 53%, p < 0.001). Co-morbidity did not appear to affect the use of spironolactone. There were few important international differences in uptake of key therapies amongst European countries with widely differing cultures and economic status. Conclusions: Guidelines appear successful in creating a relatively uniform approach to the treatment for HF due to LVSD in diverse medical cultures. Relevant co-morbidity seems to be responsible for a substantial reduction in the prescription of ACE inhibitors and beta-blockers. However, whilst co-morbidity indicates the need for greater caution, it is often not a valid contra-indication to life-saving therapy.

Differences between patients with a preserved and a depressed left ventricular function: a report from the EuroHeart Failure Survey. (Article)

2004-07-01T00:00:00Z

AIMS: Due to a lack of clinical trials, scientific evidence regarding the management of patients with chronic heart failure and preserved left ventricular function (PLVF) is scarce. The EuroHeart Failure Survey provided information on the characteristics, treatment and outcomes of patients with PLVF as compared to patients with a left ventricular systolic dysfunction (LVSD). METHODS AND RESULTS: We performed a secondary analysis using data from the EuroHeart Failure Survey, only including patients with a measurement of LV function (n = 6806). We selected two groups: patients with LVSD (54%) and patients with a PLVF (46%). Patients with a PLVF were, on average, 4 years older and more often women (55% vs. 29%, respectively, p < 0.001) as compared to LVSD patients, and were more likely to have hypertension (59% vs. 50%, p < 0.001) and atrial fibrillation (25% vs. 23%, p = 0.01). PLVF patients received less cardiovascular medication compared to PLVF patients, with the exception of calcium antagonists. Multivariate analysis revealed that LVSD was an independent predictor for mortality, while no differences in treatment effect on mortality between the two groups was observed. A sensitivity analysis, using different thresholds to separate patients with and without LVSD revealed comparable findings. CONCLUSIONS: In the EuroHeart Failure Survey, a high percentage of heart failure patients had PLVF. Although major clinical differences were seen between the groups, morbidity and mortality was high in both groups.

Irish Cardiac Society - Proceedings of the Annual General Meeting held November 1993 (Article)

1994-08-01T00:00:00Z