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

October 31, 2024 updated by: Novartis

Adoption of Novel 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart Failure Cohort
Adults hospitalized with heart failure from the Get With The Guidelines - Heart Failure (GWTG-HF) registry and enrolled in Medicare Fee-for-Service at the time of discharge. Patients had heart failure with preserved or mildly reduced ejection fraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-discharge at Day 30
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.
Post-discharge at Day 90
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.
Post-discharge at Day 180
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.
Post-discharge at Day 365

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Post-discharge at Days 30, 90, 180, and 365
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
Time Frame: Post-discharge at Days 30, 90, 180, and 365
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
Time Frame: Post-discharge at Days 30, 90, 180, and 365
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
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.
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
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.
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
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.
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
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.
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
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)
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
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Days 30, 90, 180, and 365
Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription
Time Frame: Post-discharge at Days 30, 90, 180, and 365
Post-discharge at Days 30, 90, 180, and 365
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.
Post-discharge at Days 30, 90, 180, and 365
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
Post-discharge at Days 30, 90, 180, and 365
Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
Time Frame: Post-discharge at Days 30, 90, 180, and 365
Post-discharge at Days 30, 90, 180, and 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365
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.
Post-discharge at Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696DUS07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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