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It is time for consistency in the use of biomarkers in heart failure clinical trials

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In nearly every issue of nearly every heart failure (HF) journal, one may find scientific reports regarding biomarker testing. Indeed, over the past 20 years, the role of ‘biomarker science’… Click to show full abstract

In nearly every issue of nearly every heart failure (HF) journal, one may find scientific reports regarding biomarker testing. Indeed, over the past 20 years, the role of ‘biomarker science’ has taken on a life of its own in the HF literature: analyses have focused on a broad range of topics including the role of HF markers to support clinical judgement, provide information regarding mechanism of disease, and to predict complications of the diagnosis. Increasingly, HF biomarker studies have focused on the role of circulating blood substances to reliably predict adverse outcomes such as death or HF progression; these applications may have unique uses, one of which is a growing role as a tool in HF clinical trials. As we have recently discussed,1 measurement of B-type natriuretic peptide (BNP) or its amino-terminal pro-peptide equivalent (NT-proBNP) is now ubiquitous in development programmes for HF therapeutics. Given associations with presence or severity of HF, concentrations of both peptides are routinely used (i) as an inclusion criterion to ensure enrolment of appropriate patients; (ii) as a measure of drug toxicity (especially in oncology trials); (iii) as an outcome or endpoint measure; (iv) to explain efficacy of therapeutics; and (v) as a target for therapy.1 Natriuretic peptides are by far the most frequently used for these applications.1 That said, other biomarkers such as high-sensitivity cardiac troponin are also increasingly used. Of these, the first – namely to include appropriate patients in studies – is of great interest. In the present issue of the Journal, Ferreira and colleagues report results from a substudy out of the BIOSTAT-CHF (A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure) trial.2 In this analysis, the investigators sought to develop risk models to predict cardiovascular and non-cardiovascular events. Both models included clinical and laboratory variables; and interestingly, both models incorporated NT-proBNP, however, high-sensitivity cardiac

Keywords: heart; heart failure; time consistency; clinical trials; role

Journal Title: European Journal of Heart Failure
Year Published: 2019

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