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Completed

NCT Number: NCT06671314

Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized for heart failure from 01 January 2016 to 30 September 2021.
  • Were discharged alive (any discharge disposition other than "Expired").
  • Had Mildly reduced or preserved ejection fraction (41% to 60%).
  • Had non-missing record of SAC/VAL use at discharge.
  • Continuously enrolled in Medicare Part A & B for the 12 months following the index HF hospitalization discharge date or until death.

Exclusion criteria

  • Patients who left against medical advice (AMA), were transferred to an acute care facility, or discharged to hospice care.
  • Patients who had dialysis as an in-hospital procedure.
  • Patients with a medical history of chronic dialysis.
  • Patients with an in-hospital procedure of heart transplantation.
  • Patients with a medical history of heart transplantation.
  • Patients with an in-hospital procedure of left ventricular assist device.
  • Patients with a medical history of left ventricular assist device.

Treatment and study plan

Primary outcomes

  1. Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status

    Time frame: Post-discharge at Day 30

    Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  2. Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 90

    Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  3. Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 180

    Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  4. Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 365

    Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Secondary outcomes

  1. Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  2. Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  3. Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  4. Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  5. Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.

  6. Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.

  7. Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers.

  8. Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers.

  9. Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for dialysis or end-stage kidney disease was defined as any inpatient claim having a primary diagnosis of dialysis or end-stage kidney disease (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes Z99.2, Z49, N18.5, N18.6; or ICD.9 - 585.6, V45.11, V56.0, V56.8)

  10. Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.

  11. Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0.

  12. Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.

  13. Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.

  14. Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  15. Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

    Composite measure: all-cause mortality or heart failure hospitalization.

  16. Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  17. Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Days 30, 90, 180, and 365

  18. Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.

  19. Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0.

  20. Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription

    Time frame: Post-discharge at Day 365

    Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.

  21. Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 365

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  22. Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 365

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  23. All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 365

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

  24. All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status

    Time frame: Post-discharge at Day 365

    SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

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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