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

Abstract

BackgroundThe 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 ResultsWe 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.ConclusionsThese 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.

Heart failure signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan in primary care and cardiologist settings in Germany

“…The proportion of patients in this study with HF of NYHA class III is also higher than observed in other real-world studies of sac/val. 13,17 The differences in HF severity observed between the current study and other real-world studies may be partly explained by the low number of patients in the current cohort with a recorded NYHA class. Nevertheless, the overall higher severity of HF seen in these populations compared with PARADIGM-HF may partly explain the overall lower dosing of sac/val at initiation in clinical practice.…”

“…Among patients who were prescribed sac/val 24/26 mg b.i. d. at index, there was no difference in mean (SD) SBP between those who were stably up-titrated and those who were not titrated [123 (17) mmHg vs. 122 (20) mmHg, respectively; Table 2] or in the proportion of patients with low SBP (<100 mmHg, 8% in both groups). Moreover, there were no patients with a recorded low SBP (<100 mmHg) among those Similar mean (SD) K + levels were observed in patients who were stably up-titrated and those who were not titrated regardless of whether they had a starting dose of Among patients who received 24/26 mg b.i.d.…”

The Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) trial: baseline characteristics

“…13,14,28 Looking at novel HFrEF therapies, only 11% of patients in DAPA-HF were treated with the angiotensin receptor-neprilysin inhibitor combination, sacubitril/valsartan, a finding consistent with the 13% receiving this therapy in the recent CHAMP-HF registry mentioned above. 13,14,29 However, the percentage treated with sacubitril/valsartan varied widely in DAPA-HF, from 32% in North America and 25% in Western Europe to 7% or less in other regions, perhaps reflecting different economic circumstances and health service provision. Ivabradine was also little used in recent trials and registries.…”

Heart failure around the world

“…There are considerable regional differences in patient characteristics reported in global clinical registries and trials . In the following sections, we focused on studies published after 2010 to reduce time‐lag and increase comparability between studies and registries ( Tables ) . In the PARADIGM‐HF trial, patients from AP were almost a decade younger compared to patients from NA and WE .…”

“…19 In the following sections, we focused on studies published after 2010 to reduce time-lag and increase comparability between studies and registries ( Tables 1-3). 8,11,13,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] In the PARADIGM-HF trial, patients from AP were almost a decade younger compared to patients from NA and WE. 8 This is in line with recent reports of the ASIAN-HF registry and signifies a potentially shifting burden of HF from NA, WE and EE to the AP region.…”