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OpenTrials
Completed

NCT Number: NCT05635331

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alexandroupoli, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Baseline characteristics (demographic and clinical)

    Time frame: Baseline to 12 months

    To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction

  2. Time to discontinuation of dapagliflozin

    Time frame: Baseline to 12 months

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

  3. Number of reasons for dapagliflozin treatment discontinuation

    Time frame: Baseline to 12 months

    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.

  4. Number of dapagliflozin treatment changes

    Time frame: Baseline to 12 months

    The number of participants who switch from dapagliflozin to another Heart Failure medication.

  5. Time to other HF medication discontinuation

    Time frame: Baseline 12 months

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

  6. Number of other heart failure treatment dosage changes

    Time frame: Baseline to 12 months

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

  7. Number of other heart failure treatment initiation

    Time frame: Baseline to 12 months

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

Secondary outcomes

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

    Time frame: Measured at enrollment and 3, 6, 9 and 12 months

    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.

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

    Time frame: Measured at enrollment, 3, 6, 9 and 12 months

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: EVOLUTION-HF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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