Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece

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

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-28

Study Completion Date

2024-12-03

Brief Summary

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Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality. Dapagliflozin has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in May 2020 and November 2020 respectively, for HF with reduced ejection fraction (HFrEF). The overall aim of this study is to describe the characteristics of patients initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns as well as patient-reported outcomes (PROs) including quality of life.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years as of study index date; the study index date is the date of initiation of treatment with dapagliflozin
* Patient received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction in accordance with the local dapagliflozin product label
* Signed and dated informed consent prior to enrolment in the study

Exclusion Criteria

* Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin
* Prior treatment with dapagliflozin or other Sodium Glucose co-transporter 2 inhibitor treatment
* Initiation of dapagliflozin outside of local Heart Failure label
* Diagnosis of Type 1 diabetes prior to enrolment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No