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Updated: Jun 18, 2026

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Optimizing NT-proBNP Inclusion Cut-offs for Randomized Clinical Trials in Heart Failure: Data from the Swedish Heart

Megan Schroeder1,2, Lars H Lund3,4, Christoph Gerlinger5,6

  • 1Department of Clinical Science and Education, Södersjukhuset; Karolinska Institutet, Stockholm, Sweden.

ESC Heart Failure
|March 27, 2026
PubMed
Summary

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Selecting higher N-terminal pro-B-type natriuretic peptide (NT-proBNP) cut-offs in heart failure (HF) trials improves event enrichment but increases screening failure. Tailoring NT-proBNP thresholds to specific trial goals and patient subgroups is recommended.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Biomarkers

Background:

  • N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a key biomarker for heart failure (HF).
  • Its use as an enrichment criterion in HF randomized controlled trials (RCTs) is common, but varying cut-offs complicate comparisons and trial design.
  • Optimizing NT-proBNP cut-offs is crucial for balancing patient selection with feasibility.

Purpose of the Study:

  • To provide evidence-based recommendations for selecting NT-proBNP cut-offs in HF RCTs.
  • To optimize the balance between event enrichment and screening failure across diverse HF patient subgroups.
  • To identify optimal prognostic thresholds for NT-proBNP in HF.

Main Methods:

  • Analysis of the Swedish Heart Failure Registry (SwedeHF) data from 43,750 patients.
Keywords:
Heart failureNT-proBNPcardiovascular outcomesenrichmentevent ratestrial design

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  • Application of various NT-proBNP cut-offs (200-5000 pg/mL) from prior RCTs.
  • Calculation of 1-year composite cardiovascular outcomes (CV death or HF hospitalization) and screening failure rates across subgroups defined by ejection fraction, care setting, atrial fibrillation, chronic kidney disease, and obesity.
  • Identification of optimal thresholds using Youden's index.

    • Main Results:

    • Median NT-proBNP levels varied significantly across HF subgroups (e.g., lower in HFpEF/HFmrEF vs. HFrEF, outpatients vs. inpatients, sinus rhythm vs. AF, obese vs. non-obese, and without CKD vs. with CKD).
    • Higher NT-proBNP cut-offs increased the 1-year composite CV outcome incidence but also substantially increased screening failure rates.
    • For instance, in HFrEF outpatients, increasing cut-offs from no threshold to ≥1,200 pg/mL raised the relative increase in CV events by 19% while increasing screening failure from 16.0% to 26.4%.

    Conclusions:

    • Higher NT-proBNP cut-offs enhance event enrichment in HF RCTs but lead to greater patient exclusion (screening failure).
    • Current higher cut-offs used in HF RCTs are supported by these findings.
    • Future HF trials should customize NT-proBNP cut-offs based on specific objectives, balancing enrichment with enrollment feasibility, and considering factors like obesity and CKD alongside EF and AF.