Clinical trial NCT05188144: Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom.
Official title: Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - UK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 237
Sex: ALL
Standard ages: CHILD
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 HFrEF will be eligible for enrolment by either primary or secondary care healthcare professionals 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 \<14 days after starting dapagliflozin treatment. Therefore, the earliest date at which all data collected directly from patients such as PROs may be captured is 14 days following initiation of dapagliflozin. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 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


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
* 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 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 heart failure treatment 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, 9 and 12 months
measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
timeFrame: Measured at 3, 6, 9 and 12 months
measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
timeFrame: Measured at 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Research Site
state: Berkshire
city: Truro
country: United Kingdom
facility: Research Site
state: Cornwall
city: Portadown
country: United Kingdom
facility: Research Site
state: County Armagh
city: Barnstaple
country: United Kingdom
facility: Research Site
state: Devon
city: Westcliff on Sea
country: United Kingdom
facility: Research Site
state: Essex
city: Port Talbot
country: United Kingdom
facility: Research Site
state: Glamorgan
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Stoke-on-Trent
country: United Kingdom
facility: Research Site
state: Staffordshire
city: Brighton
country: United Kingdom
facility: Research Site
state: Sussex
city: Coventry
country: United Kingdom
facility: Research Site
state: Warwickshire
Study officials:
References: