# PARADIGM-HF inclusiecriteria in routine HFrEF-zorg: 41% voldoet aan trial-eisen

*geplaatst 2026-09-14 · Hartfalen · International journal of cardiology · doi 10.1016/j.ijcard.2026.134749 · https://hartvaat.nl/2026/11/15/paradigm-hf-inclusiecriteria-in-routine-hfref-zorg-41-voldoet-aan-trial-eisen/*

Een retrospectieve analyse van drie historische Duitse HFrEF-cohorten (1994–2013) onderzocht hoeveel patiënten voldoen aan de PARADIGM-HF inclusiecriteria, inclusief natriureptide-eisen. Van de 4442 patiënten met volledige gegevens voldeed 41,2% aan de criteria; PARADIGM-achtige patiënten hadden een geavanceerder ziekteprofiel en een licht verhoogd gecorrigeerd 1-jaars mortaliteitsrisico (HR 1,08). Dit bevestigt dat PARADIGM-HF een representatieve routinezorgpopulatie selecteerde, maar benadrukt dat veel HFrEF-patiënten in de praktijk een complexer profiel vertonen. Voor de klinische praktijk ondersteunt dit het gebruik van sacubitril/valsartan bij een breed HFrEF-publiek, mits rekening wordt gehouden met een hoger basaalrisico en comorbiditeit.

## English: PARADIGM-HF eligibility in historical German HFrEF populations: clinical characteristics and 1-year outcomes.

A retrospective analysis of three historical German HFrEF cohorts (1994–2013) evaluated how many patients meet PARADIGM-HF eligibility criteria, including natriuretic peptide thresholds. Of 4,442 patients with complete data, 41.2% qualified, with PARADIGM-like patients showing more advanced disease and a modestly higher adjusted 1-year mortality risk (HR 1.08). The findings confirm that PARADIGM-HF enrolled a highly representative routine-care population, while highlighting that real-world HFrEF patients often present with a more complex clinical profile. Clinicians can be confident that sacubitril/valsartan benefits likely extend to this broader group, though baseline risk and comorbidity burden should guide monitoring.

## Abstract (original, from the publication)

BACKGROUND: In the PARADIGM-HF trial, sacubitril/valsartan improved outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Because patients enrolled in randomized trials often differ from those in routine care, we assessed the proportion and characteristics of patients fulfilling PARADIGM-HF eligibility criteria in historical German HFrEF datasets and used the PARADIGM-HF enalapril arm as descriptive clinical context. METHODS AND RESULTS: We analyzed 7605 HFrEF patients enrolled between 1994 and 2013 in three German datasets (EVITA-HF, HeLuMa, INH). Full eligibility, including natriuretic peptide (NP) criteria, was assessable in 4442 patients and confirmed in 1828 (41.2%). Mean age was 63.8 ± 13.3 years, 23.1% were female, and ischemic heart disease was the predominant etiology (51.7%). Compared with non-PARADIGM patients, PARADIGM-like patients were older, had lower LVEF, higher NP concentrations, and more comorbidities. In an exploratory pooled Cox analysis, the unadjusted HR of the PARADIGM-like patients for one-year all-cause mortality was 1.17 (95% CI 0.97-1.40) and was attenuated to 1.08 (95% CI 0.90-1.30) after adjustment for age, sex, NYHA functional class III/IV, LVEF, and renal function. Descriptive contextualization against the PARADIGM-HF enalapril arm showed overlap in clinical characteristics but also differences in disease severity, biomarker concentrations, and ascertainment conditions. CONCLUSIONS: In these historical German HFrEF datasets, full PARADIGM-HF eligibility including NP criteria was confirmed in 41.2% of patients with completely assessable eligibility information, indicating that PARADIGM-HF included a high rate of patients seen in routine care. PARADIGM-like compared to non-PARADIGM-like patients exhibited a more advanced clinical profile.

Auteurs: Anastasia Janina Hobbach, Matthias Hochadel, Christiane Angermann, Stefan Störk, Jochen Senges, Uwe Zeymer

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Bron: International journal of cardiology, https://doi.org/10.1016/j.ijcard.2026.134749. Bijgewerkt 2026-09-08T00:58:22Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.