Key result
Meeting natriuretic peptide criteria in HFpEF is associated with ~63% higher HF hospitalization and CV death.
Why the study?
Pre-amendment enrollment in PARAGON-HF before requiring elevated natriuretic peptides provided an opportunity to evaluate the influence of natriuretic peptide-based inclusion criteria in HFpEF trials.
Does meeting natriuretic peptide-based inclusion criteria enrich clinical event rates in HFpEF clinical trials?
Cohort (n=4,796)
Does meeting natriuretic peptide-based inclusion criteria enrich clinical event rates in HFpEF clinical trials?
Natriuretic peptide inclusion criteria in HFpEF trials are crucial for objectively affirming diagnoses and enriching clinical event rates.
Answers are grounded in this paper and cite their sources.
Meeting natriuretic peptide criteria enriches HFpEF event rates; supports enrichment strategies but leaves open effects on trial generalizability.
Aim Natriuretic peptides (NPs) are now routinely incorporated as key inclusion criteria in clinical trials of heart failure with preserved ejection fraction (HFpEF) as objective measures of risk. An early amendment in PARAGON‐HF required all participants to have elevated NP concentrations, but some were enrolled pre‐amendment, providing a unique opportunity to understand the influence of enrolment pathway in HFpEF clinical trials. Methods and results Among 4796 participants in PARAGON‐HF, 193 (4.0%) did not meet the final NP‐based enrolment criteria (N‐terminal pro‐B‐type natriuretic peptide >300 pg/ml for patients in sinus rhythm or >900 pg/ml for patients in atrial fibrillation/flutter). These patients had lower rates of the primary endpoint of total heart failure hospitalizations and cardiovascular death as compared with patients meeting final enrolment criteria (8.6 [6.7–11.2] events per 100 patient‐years vs. 14.0 [13.4–14.7] events per 100 patient‐years; p = 0.01). The rate ratio for the treatment effect comparing sacubitril/valsartan with valsartan was 0.85 (95% confidence interval 0.74–0.99; p = 0.04) in those who met final criteria. Conclusions Natriuretic peptides are an important tool in HFpEF clinical trials to objectively affirm diagnoses and enrich clinical event rates.
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Pabón et al. (2022) conducted a cohort in Heart failure with preserved ejection fraction (HFpEF) (n=4,796). Meeting final NP-based enrolment criteria vs. Not meeting final NP-based enrolment criteria was evaluated on Total heart failure hospitalizations and cardiovascular death (p=0.01). HFpEF patients meeting natriuretic peptide inclusion criteria had higher rates of HF hospitalization and CV death than those who did not (14.0 vs 8.6 events per 100 patient-years; p=0.01).
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