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Introduction <p>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.</p> Methods <p>This multicenter, prospective, single-arm, non-randomized, real-world, descriptive study assessed the efficacy and safety of vericiguat in Indian patients aged ≥18&#xa0;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.</p> Results <p>A total of 205 patients were enrolled (58.0 ± 13.27&#xa0;years; 73.7% male; 34.1% aged ≥ 65&#xa0;years, baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) 2490.1&#xa0;pg/mL). Left ventricular ejection fraction (LVEF) &lt; 30% was observed in 48.8% patients, 24.9% were in New York Heart Association (NYHA) class&#xa0;III. WHF events included recent HF hospitalization within &lt; 7&#xa0;days (10.7%) or 7&#xa0;days–3&#xa0;months (30.2%). Common background therapies included β-blockers (84.9%), mineralocorticoids receptor antagonist (MRAs) (80.5%), sodium-glucose cotransporter&#xa0;2 (SGLT2) inhibitors (75.6%), and angiotensin receptor-neprilysin inhibitor (ARNI) (52.7%), with 66.3% receiving triple HF therapy. Vericiguat target dose (10&#xa0;mg) was achieved by 91.1% of patients.</p> Conclusion <p>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.</p> Trial Registration <p> Clinical Trials Registry of India (CTRI/2022/11/047636).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月30日

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  • Jabir Abdulakutty,
  • Atul Abhyankar,
  • Sandeep Seth,
  • Kamal Sharma,
  • Rakesh Kumar Aggarwal,
  • Nirav Bhalani,
  • Vinod Vijan,
  • Sandeep Bansal,
  • Rajendra Kumar Premchand Jain,
  • Suvro Banerjee,
  • V. K. Chopra,
  • Abraham Oomman,
  • Pravin Kahale,
  • Priyanka Sodhi,
  • Ashish Gawde

摘要

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).