Heart Failure Clinical Trial

Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

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).

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Cohort 1 - Adult HFrEF patients

Newly 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 patients

Newly 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.

Study is for people with:

Heart Failure

Estimated Enrollment:

9230

Study ID:

NCT05613140

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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Novartis Investigative Site
East Hanover New Jersey, 07936, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

9230

Study ID:

NCT05613140

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

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