Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.

NCT ID: NCT05448872

Last Updated: 2022-11-08

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

924 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-09-15

Brief Summary

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The study is a cohort observational, retrospective, non-interventional study.

Detailed Description

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Study period:

Index date: The index date were defined as the first date of the first prescription of Sacubitril/Valsartan during inclusion period and this were used to establish the beginning of the follow-up period.

Characterization period: 6 months period before the index date were used to characterize patients.

Follow-up period: Any patients has at least 1 year of follow-up. Follow-up period went from index date to June 2020.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sacubitril/Valsartan

Heart Failure (HF) patients treated with Sac/Val

Sacubitril/Valsartan

Intervention Type DRUG

HF patients treated with Sac/Val

Interventions

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Sacubitril/Valsartan

HF patients treated with Sac/Val

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Consecutive ambulatory patients with a diagnosis of HF that attended the Outpatient Clinics for HF management and who have been prescribed Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 (inclusion period) were included in the study. To allow for at least 1-year follow-up period for any patients, the observation period ended by 30 June 2020.

In detail, all patients attending by outpatient clinics for the diagnosis and treatment of HF in the Italian Centers involved, with:

* age ≥18 years old AND
* at least one prescription of Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 were included in the study.

Exclusion Criteria

* Missing age or sex information.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

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 Investigative Site

Trieste, , Italy

Site Status

Countries

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Italy

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17954

Results for CLCZ696BIT08 from the Novartis Clinical Trials Website

Other Identifiers

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CLCZ696BIT08

Identifier Type: -

Identifier Source: org_study_id

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