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

Completed

• Conditions: Heart Failure

• Registration Number: NCT05635331
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-02
• Study Start: 2022-12-28
• Primary Completion: 2024-12-03
• Study Completion: 2024-12-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of dapagliflozin treatment changes	Baseline to 12 months	The number of participants who switch from dapagliflozin to another Heart Failure medication.
Time to discontinuation of dapagliflozin	Baseline to 12 months	Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.
Number of reasons for dapagliflozin treatment discontinuation	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.
Baseline characteristics (demographic and clinical)	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
Number of other heart failure treatment initiation	Baseline to 12 months	The number of participants who initiate new heart failure medication other than dapagliflozin.
Number of other heart failure treatment dosage changes	Baseline to 12 months	The number of participants with dosage changes for heart failure medication other than dapagliflozin.
Time to other HF medication discontinuation	Baseline 12 months	Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score	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.
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire	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.

Trial Locations

Locations (1)

Research Site; 🇬🇷 Thessaloniki, Greece