Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document
Top Cited Papers
Open Access
- 1 October 2013
- journal article
- review article
- Published by Wiley in European Journal of Heart Failure
- Vol. 15 (10), 1082-1094
- https://doi.org/10.1093/eurjhf/hft095
Abstract
Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all‐cause mortality, cause‐specific mortality, relevant non‐fatal morbidity (e.g. all‐cause and cause‐specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient‐reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA‐ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12–13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials.This publication has 105 references indexed in Scilit:
- Effect of ivabradine on recurrent hospitalization for worsening heart failure in patients with chronic systolic heart failure: the SHIFT StudyEuropean Heart Journal, 2012
- Heart Disease and Stroke Statistics—2012 UpdateCirculation, 2012
- Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO InstrumentValue in Health, 2011
- Days alive and out of hospital and the patient journey in patients with heart failure: Insights from the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programAmerican Heart Journal, 2011
- Diuretic Strategies in Patients with Acute Decompensated Heart FailureThe New England Journal of Medicine, 2011
- Eplerenone in Patients with Systolic Heart Failure and Mild SymptomsThe New England Journal of Medicine, 2011
- The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008Journal of Clinical Epidemiology, 2010
- International variations in the clinical, diagnostic, and treatment characteristics of emergency department patients with acute heart failure syndromesEuropean Journal of Heart Failure, 2010
- Trends in Length of Stay and Short-term Outcomes Among Medicare Patients Hospitalized for Heart Failure, 1993-2006JAMA, 2010
- Clinical epidemiology of heart failureHeart, 2007