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

NCT ID: NCT06671314

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-02

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CLCZ696DUS07

Identifier Type: -

Identifier Source: org_study_id

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