Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom.

NCT ID: NCT05188144

Last Updated: 2025-02-25

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

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2024-03-02

Brief Summary

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Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL

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 date of initiation of treatment with dapagliflozin
* Patient received/receiving treatment with dapagliflozin for HFrEF (EF ≤40%) 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 SGLT2i treatment
* Initiation of dapagliflozin outside of local HF label
* Diagnosis of Type 1 diabetes prior to enrolment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Reading, Berkshire, United Kingdom

Site Status

Research Site

Truro, Cornwall, United Kingdom

Site Status

Research Site

Portadown, County Armagh, United Kingdom

Site Status

Research Site

Barnstaple, Devon, United Kingdom

Site Status

Research Site

Westcliff-on-Sea, Essex, United Kingdom

Site Status

Research Site

Port Talbot, Glamorgan, United Kingdom

Site Status

Research Site

London, Greater London, United Kingdom

Site Status

Research Site

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status

Research Site

Brighton, Sussex, United Kingdom

Site Status

Research Site

Coventry, Warwickshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D169CR00001

Identifier Type: -

Identifier Source: org_study_id

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