Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- Conditions
- Heart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction
- Registration Number
- NCT06671314
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42494
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status 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 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 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 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 Outcome Measures
Name Time Method 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 All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.
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 All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.
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 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.
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 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.
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 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)
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 Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.
Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription 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.
Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription 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.
Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription 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.
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 Composite measure: all-cause mortality or heart failure hospitalization.
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 Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.
Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription 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.
Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription 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.
Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status Post-discharge at Day 365 SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status Post-discharge at Day 365 SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status Post-discharge at Day 365 SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status Post-discharge at Day 365 SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States