# Eligibility of Outpatients with Chronic Heart Failure for Vericiguat and Omecamtiv Mecarbil: From Clinical Trials to the Real-World Practice

## TL;DR

This study finds that only a small percentage of heart failure patients meet the criteria for two new drugs, vericiguat and omecamtiv mecarbil, in real-world outpatient settings.

## Contribution

The study evaluates the eligibility of CHF patients for two emerging drugs using clinical trial criteria in a real-world outpatient setting.

## Key findings

- Only 2% of patients were eligible for vericiguat and 4% for omecamtiv mecarbil.
- Many patients had left ventricular ejection fraction values above clinical trial cutoffs.
- Most patients lacked recent heart failure worsening, a key eligibility criterion.

## Abstract

Background: Several drugs are emerging as potential therapeutic resources in the context of chronic heart failure (CHF), although their impact on daily clinical practice remains unknown. The objective of this study was to investigate the theoretical eligibility for vericiguat and omecamtiv mecarbil (OM) in a real-world outpatient setting. Methods: A cross-sectional observational study was conducted, enrolling all patients with CHF who had at least one visit between January 2023 and January 2024 in a dedicated outpatient clinic of a tertiary referral center. Theoretical eligibility for vericiguat and OM in our population was assessed by adopting the criteria of the respective phase III clinical trials (VICTORIA trial for vericiguat and GALACTIC-HF trial for OM). Results: In 350 patients with CHF, the rate of individuals eligible was 2% for vericiguat and 4% for OM. A value for left ventricular ejection fraction (LVEF) over the clinical trials’ cutoffs was observed in 41% of cases for vericiguat and 69% for OM. The absence of a recent heart failure (HF) worsening was found in 78% of cases for vericiguat and 72% for OM. Conclusions: Only a small proportion of CHF patients would be eligible for vericiguat and OM in a real-world outpatient setting. The absence of a recent HF worsening and an LVEF over the established trials’ cutoffs are the main causes of non-eligibility. Further studies are required to assess the efficacy of these drugs in a wider population in order to increase the candidates for these beneficial treatments.