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
Study Type
OBSERVATIONAL
Enrollment
237
Research Site
Reading, Berkshire, United Kingdom
Research Site
Truro, Cornwall, United Kingdom
Research Site
Portadown, County Armagh, United Kingdom
Research Site
Barnstaple, Devon, United Kingdom
Research Site
Westcliff-on-Sea, Essex, United Kingdom
Research Site
Port Talbot, Glamorgan, United Kingdom
Research Site
London, Greater London, United Kingdom
Research Site
Stoke-on-Trent, Staffordshire, United Kingdom
Research Site
Brighton, Sussex, United Kingdom
Research Site
Coventry, Warwickshire, United Kingdom
Time to dapagliflozin treatment discontinuation
Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.
Time frame: Baseline to 12 months
Number of reasons for dapagliflozin treatment discontinuation
Number of reason 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.
Time frame: Baseline to 12 months
Proportion of reasons for dapagliflozin treatment discontinuation
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.
Time frame: Baseline to 12 months
Number of dapagliflozin treatment changes
The number of participants who switch to another HF medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of dapagliflozin treatment changes
The percentage of participants who switch to another HF medication other than dapagliflozin.
Time frame: Baseline to 12 months
Number of dapagliflozin treatment discontinuation
The number of participants who discontinued treatment with dapagliflozin.
Time frame: Baseline to 12 months
Percentage of dapagliflozin treatment discontinuation
The percentage of participants who discontinued treatment with dapagliflozin.
Time frame: Baseline to 12 months
Time to other heart failure treatment discontinuation
Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
Time frame: Baseline to 12 months
Number of other heart failure treatment initiation
The number of participants who initiate new heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of other heart failure treatment initiation
The percentage of participants who initiate new heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Number of other heart failure treatment dosage changes
The number of participants with dosage changes for heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of other heart failure treatment dosage changes
The percentage of participants with dosage changes for heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Number of other heart failure treatment discontinuation
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of other heart failure treatment discontinuation
The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Time frame: Baseline to 12 months
Time to glucose lowering medication discontinuation
Time from initiation of glucose lowering medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
Time frame: Baseline to 12 months
Number of glucose lowering medication initiation
The number of participants who initiate new glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of glucose lowering medication initiation
The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Number of glucose lowering medication dosage changes
The number of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of glucose lowering medication dosage changes
The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Number of glucose lowering medication discontinuation
The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Percentage of glucose lowering medication discontinuation
The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Time frame: Baseline to 12 months
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
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.
Time frame: Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
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.
Time frame: Measured at 3, 6, 9 and 12 months
Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
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.
Time frame: Measured at 3, 6, 9 and 12 months
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