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

J Am Heart Assoc. 2018 Jun 12;7(12):e009237. doi: 10.1161/JAHA.118.009237.


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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aminobutyrates / adverse effects
  • Aminobutyrates / therapeutic use*
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Biphenyl Compounds
  • Drug Combinations
  • Female
  • Heart Failure / diagnosis
  • Heart Failure / drug therapy*
  • Heart Failure / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Neprilysin / antagonists & inhibitors*
  • Observational Studies as Topic / methods*
  • Patient Selection*
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic / methods*
  • Recovery of Function
  • Registries
  • Stroke Volume / drug effects*
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Treatment Outcome
  • Valsartan
  • Ventricular Function, Left / drug effects*


  • Aminobutyrates
  • Angiotensin II Type 1 Receptor Blockers
  • Biphenyl Compounds
  • Drug Combinations
  • Protease Inhibitors
  • Tetrazoles
  • Valsartan
  • Neprilysin
  • sacubitril and valsartan sodium hydrate drug combination