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Am J Cardiol. 2015 Oct 15;116(8):1304-10. doi: 10.1016/j.amjcard.2015.07.049. Epub 2015 Jul 29.

Using Natriuretic Peptides for Selection of Patients in Acute Heart Failure Clinical Trials.

Author information

1
Department of Cardiology/Heart Failure and Transplantation, The Ohio State University, Columbus, Ohio. Electronic address: sakima.smith@osumc.edu.
2
Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina.
3
Bayer Pharmaceuticals, Wuppertal, Germany.
4
Department of Anesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, Paris, France.
5
Department of Anesthesiology, Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
6
Feinberg School of Medicine, Center for Cardiovascular Innovation, Department of Cardiology, Northwestern University, Chicago, Illinois.
7
Department of Cardiology, University of Michigan School of Medicine, Ann Arbor, Michigan.
8
Department of Cardiology, Centre Hospitalier Universitaire, University Henri Poincaré, France.
9
Division of Cardiology, Stony Brook University, Stony Brook, New York.
10
Department of Cardiology/Heart Failure and Transplantation, The Ohio State University, Columbus, Ohio.

Abstract

Acute heart failure (AHF) is a complex syndrome with presentations ranging from hypotensive cardiogenic shock to hypertensive emergency with pulmonary edema. Most patients with AHF present with worsening of chronic HF signs and symptoms over days to weeks, and significant heterogeneity exists. It can, therefore, be challenging to characterize the overall population. The complexity of defining the AHF phenotype has been cited as a contributing cause for neutral results in most pharmacologic trials in patients with AHF. Dyspnea has been a routine inclusion criterion for AHF for over a decade, but the utility of current instruments for dyspnea assessment has been called into question. Furthermore, the threshold of clinical severity that prompts patient admission of an HF clinic visit may vary substantially across regions in global trials. Therefore, the inclusion of cardiac-specific biomarkers has been incorporated into AHF trials as 1 strategy to support inclusion of the target patient population and potentially enrich the population with patients at risk for clinical outcomes. In conclusion, we discuss strategies to support appropriate patient selection in AHF trials with an emphasis on using biomarker criteria that may improve the likelihood of success with future AHF clinical trials.

PMID:
26282727
DOI:
10.1016/j.amjcard.2015.07.049
[Indexed for MEDLINE]

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