Variable impact of combining fatal and nonfatal end points in heart failure trials

H Skali, MA Pfeffer, J Lubsen, SD Solomon - Circulation, 2006 - Am Heart Assoc
Randomized clinical trials (RCTs) are a cornerstone of evidence-based medicine. Their
design, implementation, and interpretation are sometimes subject to flaws and errors. To …

Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document

F Zannad, AA Garcia, SD Anker… - European journal of …, 2013 - Wiley Online Library
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 …

Choice of clinical outcomes in randomized trials of heart failure therapies: disease-specific or overall outcomes?

S Yusuf, A Negassa - American heart journal, 2002 - Elsevier
Background There are different views regarding the appropriateness of using cause-specific
events or all events as the primary outcome of clinical trials. Methods This is a methodologic …

Time to move on from 'time-to-first': should all events be included in the analysis of clinical trials?

SD Anker, JJV McMurray - European Heart Journal, 2012 - academic.oup.com
Not that long ago a diagnosis of heart failure was a death sentence. For example, a patient
hospitalized with heart failure in the late 1980s had a median survival of, 1.25 years after …

Trends in heart failure clinical trials from 2001–2012

AS Tahhan, M Vaduganathan, A Kelkar… - Journal of cardiac …, 2016 - Elsevier
Background A systematic assessment of the temporal trends in heart failure (HF) clinical
trials is lacking. Methods and Results A total of 154 phase II–IV HF trials including 162,725 …

Timing and duration of interventions in clinical trials for patients with hospitalized heart failure

CN Marti, GC Fonarow, M Gheorghiade… - Circulation: Heart …, 2013 - Am Heart Assoc
Current data suggest that patients with HHF have lower inhospital but higher postdischarge
risk for adverse events compared with patients with acute myocardial infarction. The patients …

Key issues in end point selection for heart failure trials: composite end points

JD Neaton, G Gray, BD Zuckerman… - Journal of cardiac failure, 2005 - Elsevier
BACKGROUND: Composite outcomes are commonly used in heart failure trials. The aim of
this article is to discuss the advantages and disadvantages of composite outcomes and …

Comparison of outcome adjudication by investigators and by a central end point committee in heart failure trials: experience of the SHIFT heart failure study

B Tyl, J Lopez Sendon, JS Borer… - Circulation: Heart …, 2020 - Am Heart Assoc
Background: The usefulness of adjudication by central end point committees (CECs) is
poorly assessed in heart failure (HF) trials. We aimed to assess its impact on the outcome of …

Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium

WT Abraham, MA Psotka, M Fiuzat, G Filippatos… - Heart Failure, 2020 - jacc.org
Abstract The Heart Failure Academic Research Consortium is a partnership between the
Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of …

A global rank end point for clinical trials in acute heart failure

GM Felker, AS Maisel - Circulation: Heart Failure, 2010 - Am Heart Assoc
Hospitalization for acute heart failure (AHF) is a major public health problem, with 1 million
hospitalizations annually in the United States. 1 The development of new therapies for …