Characteristics and Treatments of Patients Enrolled in the CHAMP-HF Registry Compared With Patients Enrolled in the PARADIGM-HF Trial.

BACKGROUND

The US Food and Drug Administration approved sacubitril/valsartan for patients with chronic heart failure (HF) with reduced ejection fraction in 2015 on the basis of the results of the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor Neprilysin Inhibitor] With ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. There are limited data assessing the generalizability of PARADIGM-HF trial participants to a broader population of patients with HF with reduced ejection fraction routinely encountered in outpatient clinical practice.

METHODS AND RESULTS

We compared the baseline characteristics of patients in the PARADIGM-HF trial with those in the CHAMP-HF (Change the Management of Patients With Heart Failure) study a large US outpatient registry of patients with HF with reduced ejection fraction. Patients in the PARADIGM-HF trial (n=8442) were similar to those in the CHAMP-HF registry (n=3497) in terms of age (mean, 64 versus 66 years), sex (22% versus 29% women), New York Heart Association class III to IV (25% versus 32%), systolic blood pressure (mean, 121 versus 121 mm Hg), left ventricular ejection fraction (mean, 29% versus 29%), and other key baseline characteristics. The median (25th-75 percentile) Meta-Analysis Global Group in Chronic Heart Failure risk scores were similar for the 2 studies (20 [16-24] versus 22 [8-27]). Despite this, only 13% of patients in the CHAMP-HF registry were prescribed sacubitril/valsartan at baseline.

CONCLUSIONS

These data suggest participants randomized in the PARADIGM-HF trial have similar baseline characteristics to those encountered in routine outpatient clinical practice, but there is a substantial lag in the adoption of sacubitril/valsartan for patients with chronic HF with reduced ejection fraction.