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

Novartis

Status: Completed

Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure With Reduced Ejection Fraction

Study type: Observational

Funder types: Industry

Identifiers

NCT06671314

CLCZ696DUS07

Details and patient eligibility

About

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.

Enrollment: 42,494 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

42,494 participants in 1 patient group

Heart Failure Cohort

Description:

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.