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

NCT05188144 | Completed

• 1 other identifier: D169CR00001
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (21)

• Time to dapagliflozin treatment discontinuation

  Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.

  Baseline to 12 months

• Number of reasons for dapagliflozin treatment discontinuation

  Number of reason for dapagliflozin treatment discontinuation as noted by a health care professional will extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.

  Baseline to 12 months

• Proportion of reasons for dapagliflozin treatment discontinuation

  Proportion of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.

  Baseline to 12 months

• Number of dapagliflozin treatment changes

  The number of participants who switch to another HF medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of dapagliflozin treatment changes

  The percentage of participants who switch to another HF medication other than dapagliflozin.

  Baseline to 12 months

• Number of dapagliflozin treatment discontinuation

  The number of participants who discontinued treatment with dapagliflozin.

  Baseline to 12 months

• Percentage of dapagliflozin treatment discontinuation

  The percentage of participants who discontinued treatment with dapagliflozin.

  Baseline to 12 months

• Time to other heart failure treatment discontinuation

  Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.

  Baseline to 12 months

• Number of other heart failure treatment initiation

  The number of participants who initiate new heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of other heart failure treatment initiation

  The percentage of participants who initiate new heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Number of other heart failure treatment dosage changes

  The number of participants with dosage changes for heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of other heart failure treatment dosage changes

  The percentage of participants with dosage changes for heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Number of other heart failure treatment discontinuation

  The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of other heart failure treatment discontinuation

  The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin.

  Baseline to 12 months

• Time to glucose lowering medication discontinuation

  Time from initiation of glucose lowering medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.

  Baseline to 12 months

• Number of glucose lowering medication initiation

  The number of participants who initiate new glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of glucose lowering medication initiation

  The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

• Number of glucose lowering medication dosage changes

  The number of participants with dosage changes for glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of glucose lowering medication dosage changes

  The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

• Number of glucose lowering medication discontinuation

  The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

• Percentage of glucose lowering medication discontinuation

  The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.

  Baseline to 12 months

Secondary Outcomes (3)

• Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  Measured at 3, 6, 9 and 12 months

• Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire

  Measured at 3, 6, 9 and 12 months

• Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score

  Measured at 3, 6, 9 and 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received treatment with dapagliflozin for HFrEF will be eligible for enrolment by either primary or secondary care healthcare professionals from both outpatient and inpatient settings. In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enrol the patient into the study. To help ensure this, patients cannot be enrolled \<14 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 14 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 days and ≤60 days prior to enrolment onto the study. Data on other parameters may be obtained at the date of initiation of dapagliflozin by extracting this information retrospectively from medical charts.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Research Site

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Research Site

Portadown, County Armagh, BT63 5QQ, United Kingdom

Location

Research Site

Barnstaple, Devon, EX31 4JB, United Kingdom

Location

Research Site

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

Research Site

Port Talbot, Glamorgan, SA12 7BR, United Kingdom

Location

Research Site

London, Greater London, SE5 9RS, United Kingdom

Location

Research Site

Stoke-on-Trent, Staffordshire, AT4 6QG, United Kingdom

Location

Research Site

Brighton, Sussex, BN2 5BE, United Kingdom

Location

Research Site

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Related Links

• redacted CSR Synopsis

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: January 12, 2022
• Study Start: November 29, 2021
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

GB (10)