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

Heart Failure Clinical Trial

— EVOLUTION-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05635331
• Other study ID #: D1699R00046
• Status: Active, not recruiting
• Start date: December 28, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 257
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chania
Greece	Research Site	Heraclion
Greece	Research Site	Ioannina
Greece	Research Site	Ioannina
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of dapagliflozin treatment changes	The number of participants who switch from dapagliflozin to another Heart Failure medication.	Baseline to 12 months
Primary	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
Primary	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
Primary	Number of other heart failure treatment initiation	The number of participants who initiate new heart failure medication other than dapagliflozin.	Baseline to 12 months
Secondary	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
Secondary	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