Clinical trial NCT06671314: Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Official title: Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 42494
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status
timeFrame: Post-discharge at Day 30
measure: Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 90
measure: Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 180
measure: Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 365
Secondary outcomes:
measure: Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: 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
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Days 30, 90, 180, and 365
measure: Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription
timeFrame: Post-discharge at Day 365
measure: Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 365
measure: Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 365
measure: All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 365
measure: All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
timeFrame: Post-discharge at Day 365
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: