What This Means
This research examined how many patients with heart failure and reduced pumping function (HFrEF) treated in routine German clinical care would have been eligible to participate in the landmark PARADIGM-HF clinical trial, which demonstrated that the drug sacubitril/valsartan improves outcomes compared to enalapril. The researchers analyzed records from 7,605 heart failure patients enrolled in three German registries or studies between 1994 and 2013. Among the roughly 4,400 patients for whom all necessary eligibility information—including blood biomarker (natriuretic peptide) levels—could be assessed, about 41% met all the PARADIGM-HF entry criteria. This suggests that the PARADIGM-HF trial enrolled a patient population that substantially overlaps with patients seen in everyday clinical practice.
Patients who met the PARADIGM-HF eligibility criteria tended to have more severe disease than those who did not qualify: they were older, had weaker heart function (lower ejection fraction), higher biomarker levels indicating heart stress, and more additional health conditions. Despite this more advanced clinical profile, their one-year risk of death was only modestly and non-significantly higher than non-eligible patients, particularly after accounting for differences in age, sex, heart function, and kidney function. When the German registry patients who met eligibility criteria were compared descriptively to patients in the enalapril (control) arm of PARADIGM-HF, there was considerable overlap in clinical features, though some differences in disease severity and measurement conditions existed.
This research suggests that the results of the PARADIGM-HF trial may be broadly applicable to HFrEF patients seen in routine clinical practice in Germany and potentially other similar healthcare settings. The finding that about 4 in 10 real-world HFrEF patients meet trial eligibility criteria supports the generalizability of the trial, while also highlighting that eligibility assessment requires complete biomarker data, which may not always be available in everyday care. The more advanced disease profile of eligible patients underscores the importance of timely identification and treatment of high-risk heart failure patients.