Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF)

NCT05465213 | Completed

• 1 other identifier: D1699R00036
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 8

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

Keywords

Heart Failure; Heart Failure with Reduced Ejection Fraction; HFrEF; Dapagliflozin; Real-world

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 reasons for dapagliflozin treatment discontinuation as noted by a health care professional will be 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 HF medication 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 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 and 12 months

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

  Measured at 3, 6 and 12 months

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

  Measured at 3, 6 and 12 months

Study Arms (2)

Retrospective cohort

Patients who have initiated treatment with dapagliflozin for HFrEF between 1st of March 2021 and 31st of October 2021 (prior to study initiation date).

Prospective Cohort

Patients who have started treatment with dapagliflozin for HFrEF from 1st April 2022 onwards. At least 30 days must have elapsed (but no more than 60 days) from first prescription of dapagliflozin before a patient can be enrolled.

Eligibility Criteria

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

Study Population

Patients with registered hospital diagnosis of HF who have received treatment with dapagliflozin for HFrEF will be eligible for enrolment by physicians 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 \<30 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 30 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥30 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:
• Retrospective study: their dapagliflozin initiation was between 1st of March 2021 and 31st of October 2021.
• Prospective study: their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrollment onto the study
• Signed and dated informed consent prior to enrollment in the study (only applicable for the prospective cohort, informed consent waiver will be requested for retrospective cohort)

You may not qualify if:

• Patient is enrolled less than 30 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 (8)

Research Site

Almada, Portugal

Location

Research Site

Amadora, Portugal

Location

Research Site

Coimbra, Portugal

Location

Research Site

Lisbon, Portugal

Location

Research Site

Penafiel, Portugal

Location

Research Site

Porto, Portugal

Location

Research Site

Setúbal, Portugal

Location

Research Site

Vila Real, Portugal

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: June 28, 2022
• First Posted: July 19, 2022
• Study Start: November 28, 2022
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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

PT (8)