NCT05613140

Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

A Pre-post Analysis of Healthcare Resource Utilization and Costs of Care in a New User Cohort of Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,230 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).

Detailed description

This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs. Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2). The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	sacubitril/valsartan	Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-11-05
• Completion: 2021-11-05
• First posted: 2022-11-14
• Last updated: 2022-11-15

Locations

1 site across 1 country: United States