Clinical trial NCT05465213: Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF)
Official title: Early Treatment of Heart Failure: a Non-interventional Observational Study of Patients With Heart Failure and Initiated on Dapagliflozin in Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Heart Failure with Reduced Ejection Fraction
HFrEF
Dapagliflozin
Real-world
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 283
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 with registered hospital diagnosis of HF who have received treatment with dapagliflozin for HFrEF will be eligible for enrolment by physicians from both outpatient and inpatient settings. In all cases, the decision to treat a patient with dapagliflozin must be made prior to the decision to enrol the patient into the study. To help ensure this, patients cannot be enrolled \<30 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 30 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrolment onto the study. Data on other parameters may be obtained at the date of initiation of dapagliflozin by extracting this information retrospectively from medical charts.

Brief summary: Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL.

Detailed description: Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL. EVOLUTION-HF will help obtaining relevant insights from clinical practice through the analysis of detailed data on heart failure symptoms/severity for patients receiving dapagliflozin in real-world setting.

Study aims are to describe the characteristics of patients newly prescribed dapagliflozin for the treatment of HFrEF, to provide early insights into real-world dapagliflozin treatment patterns, and to describe patients-reported outcomes, medication adherence and work productivity losses in these patients.

This observational, longitudinal cohort study will include patients with a physician diagnosis of HFrEF who are initiated on dapagliflozin in clinical practice. The study will include 2 cohorts of patients: one fully retrospective and one prospective cohort, in which patient-reported outcomes (PROs) including quality of life will be collected

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin
* Patient received/receiving treatment with dapagliflozin for HFrEF (EF ≤40%) in accordance with the local dapagliflozin product label:

  * Retrospective study: their dapagliflozin initiation was between 1st of March 2021 and 31st of October 2021.
  * Prospective study: their dapagliflozin initiation was ≥30 days and ≤60 days prior to enrollment onto the study
* Signed and dated informed consent prior to enrollment in the study (only applicable for the prospective cohort, informed consent waiver will be requested for retrospective cohort)

Exclusion Criteria:

* Patient is enrolled less than 30 days following initiation of dapagliflozin
* Prior treatment with dapagliflozin or other SGLT2i treatment
* Initiation of dapagliflozin outside of local HF label
* Diagnosis of Type 1 diabetes prior to enrolment

Primary outcomes:
measure: Time to dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Number of reasons for dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Proportion of reasons for dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Number of dapagliflozin treatment changes
timeFrame: Baseline to 12 months
measure: Percentage of dapagliflozin treatment changes
timeFrame: Baseline to 12 months
measure: Number of dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Percentage of dapagliflozin treatment discontinuation
timeFrame: Baseline to 12 months
measure: Time to other HF medication discontinuation
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment initiation
timeFrame: Baseline to 12 months
measure: Percentage of other heart failure treatment initiation
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment dosage changes
timeFrame: Baseline to 12 months
measure: Percentage of other heart failure treatment dosage changes
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment discontinuation
timeFrame: Baseline to 12 months
measure: Percentage of other heart failure treatment discontinuation
timeFrame: Baseline to 12 months
measure: Time to glucose lowering medication discontinuation
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication initiation
timeFrame: Baseline to 12 months
measure: Percentage of glucose lowering medication initiation
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication dosage changes
timeFrame: Baseline to 12 months
measure: Percentage of glucose lowering medication dosage changes
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication discontinuation
timeFrame: Baseline to 12 months
measure: Percentage of glucose lowering medication discontinuation
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: Measured at 3, 6 and 12 months
measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
timeFrame: Measured at 3, 6 and 12 months
measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
timeFrame: Measured at 3, 6 and 12 months
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Penafiel
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Vila Real
country: Portugal
facility: Research Site
Study officials:
References: