Study Design and Baseline Characteristics of the VERINA Study: Phase IV Evidence of Vericiguat for Worsening Heart Failure Management

Abstract

Introduction: Patients with heart failure with reduced ejection fraction (HFrEF) experience higher rates of in-hospital and all-cause mortality. On the basis of the VERINA trial, vericiguat is indicated for patients who have had a worsening heart failure (WHF) event despite optimal heart failure (HF) therapy, or for those with tolerability concerns. Methods: This multicenter, prospective, single-arm, non-randomized, real-world, descriptive study assessed the efficacy and safety of vericiguat in Indian patients aged ≥18 years with chronic HFrEF who were vericiguat-naïve and started treatment as per the local label. This analysis is based on interim data and the final results may differ. The main endpoint was a composite of cardiovascular (CV) death or first HF hospitalization. Secondary endpoints included each component of the primary outcome, all-cause death, and safety. Dose-titration parameters, including time to reach and duration at various dose levels, were also assessed. Results: A total of 205 patients were enrolled (58.0 ± 13.27 years; 73.7% male; 34.1% aged ≥ 65 years, baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) 2490.1 pg/mL). Left ventricular ejection fraction (LVEF) < 30% was observed in 48.8% patients, 24.9% were in New York Heart Association (NYHA) class III. WHF events included recent HF hospitalization within < 7 days (10.7%) or 7 days–3 months (30.2%). Common background therapies included β-blockers (84.9%), mineralocorticoids receptor antagonist (MRAs) (80.5%), sodium-glucose cotransporter 2 (SGLT2) inhibitors (75.6%), and angiotensin receptor-neprilysin inhibitor (ARNI) (52.7%), with 66.3% receiving triple HF therapy. Vericiguat target dose (10 mg) was achieved by 91.1% of patients. Conclusion: This study enrolled high-risk patients with recent decompensation event consistent with the VICTORIA trial. The usage of standard of care (SoC) was as per current clinical practice in HF; VERINA enrolled 52.7% on ARNI compared to 14.5% in VICTORIA and 75.6% on SGLT2i compared to 2% in VICTORIA. Safety data did not reveal any new safety signals or adverse trends in the interim analysis. Trial Registration: Clinical Trials Registry of India (CTRI/2022/11/047636).