Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Sponsor
- Novartis
- Enrollment
- 42494
- Locations
- 1
- Primary Endpoint
- Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
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.
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
- Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- 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(Post-discharge at Days 30, 90, 180, and 365)
- Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
- Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
- Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
- Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
- Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
- Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
- Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
- Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
- Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
- Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
- All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
- All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)