Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece (EVOLUTION-HF)

Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - GREECE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• Greece
  • Alexandroupoli, Greece, 68100
    • Research Site
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 11528
    • Research Site
  • Athens, Greece, 12462
    • Research Site
  • Athens, Greece, 14233
    • Research Site
  • Athens, Greece, 11526
    • Research Site
  • Athens, Greece, 17674
    • Research Site
  • Chania, Greece, 73300
    • Research Site
  • Heraclion, Greece, 71409
    • Research Site
  • Ioannina, Greece, 45500
    • Research Site
  • Ioannina, Greece, 45445
    • Research Site
  • Patra, Greece, 26504
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
  • Thessaloniki, Greece, 54636
    • Research Site
  • Thessaloniki, Greece, 56429
    • Research Site
  • Thessaloniki, Greece, 54642
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction will be eligible for enrolment by physicians from outpatient and inpatient settings. Eligible patients will be selected after they have been identified in paper or electronic medical records by the participating investigator. Consecutive patients prescribed dapagliflozin should be identified by the investigator and, unless failing to meet the inclusion and exclusion criteria, should be invited to participate. Patients will only be enrolled after they have given consent to participate in the study.

In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enroll the patient into the study. To help ensure this, at least 14 days must have elapsed (but no more than 60 days) from the date of initiation of dapagliflozin before a patient can be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of other heart failure treatment initiation	The number 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
Baseline characteristics (demographic and clinical)	To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction	Baseline to 12 months
Time to discontinuation of dapagliflozin	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
Number of dapagliflozin treatment changes	The number of participants who switch from dapagliflozin to another Heart Failure medication.	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 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score	The KCCQ is a 23-item questionnaire that quantifies physical limitations, self-efficacy, social interference and quality of life. Summary scores will be examined at each assessment point during follow-up. For each of the assessment periods, descriptive statistics for the observed value, change from baseline and the 95% two-sided confidence interval for the mean change will be presented. The proportions of participants with overall health status classified as poor, fair, good, and excellent will be examined at each assessment point. Additionally, the proportions of participants who experience clinically meaningful changes in overall health status: improvement (≥5 point increase), deterioration (≥5 point decrease), and stable (<5 point increase or decrease) will be examined at each assessment point.	Measured at enrollment and 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire	The MARS-5 is five-item self-report adherence scale which assesses both intentional and non-intentional non-adherence. Respondents rate the frequency with which the five different medication-taking behaviors occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence.	Measured at enrollment, 3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: D1699R00046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing 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.
• IPD Sharing 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No