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Completed

NCT Number: NCT05613140

Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

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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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sacubitril/valsartan

Drug

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).

Primary outcomes

  1. Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.

Secondary outcomes

  1. Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Number of HF-related hospitalizations was defined as the number of acute inpatient hospitalizations with a discharge diagnosis of HF in any position.

  2. Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Number of all-cause hospitalizations was as the number of acute inpatient hospitalizations for any reason.

  3. Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    An UHF visit was defined as any of the following:

    i) a patient with a place of service (POS) code 20, which corresponds to urgent care facility ii) a patient with an ER visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0450, 0451, 0452, 0456 or 0459 iii) a patient with an urgent care clinic visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0516 or 0526 iv) a patient with a hospital observational stay (POS code = 22, 23), identified from revenue code 0762

  4. Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Number of WHF episodes was defined as a composite outcome of HF-specific hospitalizations and UHF visits.

  5. Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Costs of HF-specific hospitalizations was defined as the sum of payer paid amounts for acute inpatient hospitalizations with a primary discharge diagnosis of HF.

  6. Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Costs of HF-related hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations with a discharge diagnosis of HF in any position.

  7. Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Costs of all-cause hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations for any reason.

  8. Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Costs of UHF visits were defined as the sum of payer paid amounts for UHF visits.

  9. Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    Costs of WHF episodes were defined as the sum of payer paid amounts for HF-specific hospitalizations and UHF visits.

  10. Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    HF-related costs were defined as the sum of payer paid amounts for medical claims with a diagnosis of HF in any position.

  11. Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    All-cause medical costs were defined as the sum of payer paid amounts for all medical claims.

  12. Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    All-cause pharmacy costs were defined as the sum of payer paid amounts for all pharmacy claims.

  13. Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan

    Time frame: Baseline, 12 months post initiation of sacubitril/valsartan

    All-cause total cost of care were defined as the sum of all-cause medical costs and all-cause pharmacy costs.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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