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Completed
NCT05613140
Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
Conditions: Chronic Heart Failure
Sex: All
Ages: 18 Years – 99 Years
Enrollment: 9230
Sponsor: Novartis Pharmaceuticals
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:Cohort 1 - Adult HFrEF patientsNewly initiated sacubitril/valsartan during the cohort identification period;Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x,
I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;That are ≥ 18 years old at index date;That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.Cohort 2 - Adult CHF patientsNewly initiated sacubitril/valsartan during the cohort identification period;Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x,
I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;That are ≥ 18 years old at index date;That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.Exclusion Criteria:- Patients who died during the post-index period will be excluded.
Source: ClinicalTrials.gov (NCT05613140). StuddyBuddy aggregates publicly available trial information.