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

Abstract

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–75th 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.

Keywords

• angiotensin receptor neprilysin inhibitor
• quality improvement
• registry
• sacubitril/valsartan