Clinical trial NCT05635331: Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline characteristics (demographic and clinical)
timeFrame: Baseline to 12 months
measure: Time to discontinuation of dapagliflozin
timeFrame: Baseline to 12 months
measure: Number of reasons for dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Number of dapagliflozin treatment changes
timeFrame: Baseline to 12 months
measure: Time to other HF medication discontinuation
timeFrame: Baseline 12 months
measure: Number of other heart failure treatment dosage changes
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment initiation
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: Measured at enrollment and 3, 6, 9 and 12 months
measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
timeFrame: Measured at enrollment, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Heraclion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
References: