Heart Failure
Conditions
Keywords
Heart Failure, Heart Failure with Reduced Ejection Fraction, HFrEF, Dapagliflozin, Real-world
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of glucose lowering medication discontinuation | Baseline to 12 months | The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin. |
| Number of glucose lowering medication dosage changes | Baseline to 12 months | The number of participants with dosage changes for glucose lowering medication other than dapagliflozin. |
| Percentage of glucose lowering medication dosage changes | Baseline to 12 months | The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin. |
| Number of glucose lowering medication discontinuation | Baseline to 12 months | The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin. |
| Time to dapagliflozin treatment discontinuation | 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. |
| Proportion of reasons for dapagliflozin treatment discontinuation | Baseline to 12 months | Proportion of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented. |
| Number of dapagliflozin treatment changes | Baseline to 12 months | The number of participants who switch to another HF medication other than dapagliflozin. |
| Percentage of dapagliflozin treatment changes | Baseline to 12 months | The percentage of participants who switch to another HF medication other than dapagliflozin. |
| Number of dapagliflozin treatment discontinuation | Baseline to 12 months | The number of participants who discontinued treatment with dapagliflozin. |
| Percentage of dapagliflozin treatment discontinuation | Baseline to 12 months | The percentage of participants who discontinued treatment with dapagliflozin. |
| Time to other HF medication discontinuation | Baseline to 12 months | Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication. |
| Number of other heart failure treatment initiation | Baseline to 12 months | The number of participants who initiate new heart failure medication other than dapagliflozin. |
| Percentage of other heart failure treatment initiation | Baseline to 12 months | The percentage 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. |
| Percentage of other heart failure treatment dosage changes | Baseline to 12 months | The percentage of participants with dosage changes for heart failure medication other than dapagliflozin. |
| Number of other heart failure treatment discontinuation | Baseline to 12 months | The number of participants who discontinue treatment with heart failure medication other than dapagliflozin. |
| Percentage of other heart failure treatment discontinuation | Baseline to 12 months | The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin. |
| Time to glucose lowering medication discontinuation | Baseline to 12 months | Time from initiation of glucose lowering medication until the time at which participants discontinued treatment with that medication. |
| Number of glucose lowering medication initiation | Baseline to 12 months | The number of participants who initiate new glucose lowering medication other than dapagliflozin. |
| Percentage of glucose lowering medication initiation | Baseline to 12 months | The percentage of participants who initiate new glucose lowering medication other than dapagliflozin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire | Measured at 3, 6 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 behaviours occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence. The MARS-5 has been shown to be reliable and valid across a variety of health conditions, including cardiovascular and pulmonary diseases. Only applicable to Prospective cohort. |
| Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score | Measured at 3, 6 and 12 months | The WPAI is a validated instrument to measure impairments in paid and unpaid work and activities. It measures absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness) as well as the impairments in unpaid activity because of health problems during the past seven days. It has been validated to quantify work impairments for numerous diseases such as asthma, psoriasis, irritable bowel syndrome, and Crohn's disease, but has not yet been validated for use in heart failure participants. Scores will be derived from the overall work impairment at each timepoint and then changes of from baseline will be reported. Only applicable to Prospective cohort. |
| Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score | Measured at 3, 6 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. Only applicable to Prospective cohort. |
Countries
Portugal
Outcome results
None listed