Biomarker changes as surrogate endpoints in early-phase trials in heart failure with reduced ejection fraction.

ABSTRACT:

Aims

No biomarker has achieved widespread acceptance as a surrogate endpoint for early-phase heart failure (HF) trials. We assessed whether changes over time in a panel of plasma biomarkers were associated with subsequent morbidity/mortality in HF with reduced ejection fraction (HFrEF).

Methods and results

In 1040 patients with HFrEF from the BIOSTAT-CHF cohort, we investigated the associations between changes in the plasma concentrations of 30 biomarkers, before (baseline) and after (9 months) attempted optimization of guideline-recommended therapy, on top of the BIOSTAT risk score and the subsequent risk of HF hospitalization/all-cause mortality using Cox regression models. C-statistics were calculated to assess discriminatory power of biomarker changes/month-nine assessme

SUBMITTER: Savarese G 

PROVIDER: S-EPMC9288797 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature