Cardiovascular Diseases, Heart Diseases, Heart Failure
Conditions
Keywords
Heart Failure with preserved ejection fraction (HFpEF), Heart Failure with mildly reduced ejection fraction (HFmrEF), 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). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
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 in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with: * preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%) * OR reduced ejection fraction (HFrEF EF ≤40%) * Patient is enrolled within 14 to 90 days following initiation of dapagliflozin * Signed and dated informed consent prior to enrolment in the study
Exclusion criteria
* Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin * Prior treatment with dapagliflozin or other SGLT2i treatment * Initiation of dapagliflozin outside of the local HF label * Diagnosis of Type 1 diabetes prior to enrolment * Current or planned participation in a clinical trial using an investigational medical product for treating HF * Patient is involved in the planning and/or conduction of the study * Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to discontinuation of dapagliflozin | Baseline to 12 months | Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason (from the perspective of the prescriber). |
| Reasons for discontinuation of dapagliflozin | Baseline to 12 months | Reasons for discontinuation (from the perspective of the prescriber) of patients initiated on dapagliflozin for HF will be described. |
| Dose changes of dapagliflozin | Baseline to 12 months | The number of participants with doses changes for dapagliflozin |
| Number of patients with dapagliflozin treatment interruptions | Baseline to 12 month | The number of participants who discontinue treatment with dapagliflozin. |
| Treatment switches from dapagliflozin to other SGLT2i | Baseline to 12 months | The number of participants who switch from dapagliflozin to another SGLT2i (Sodium-glucose cotransporter-2 inhibitor) treatment for HF. |
| Time to other heart failure treatment 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. |
| 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. |
| 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. |
| Number of glucose lowering medication initiation | Baseline to 12 months | The number of participants who initiate new 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. |
| Number of glucose lowering medication discontinuation | Baseline to 12 months | The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score | Measured at 3, 6, 9 and 12 months | The KCCQ is a 23-item questionnaire that quantifies physical limitations, self-efficacy, social interference and quality of life. Several summary scores may be calculated including: Total Symptom score (measuring symptom frequency and symptom burden), Physical limitation score (measuring limitations in common physical activities), Clinical Summary score (measure of physical limitations and total symptoms), and an Overall Summary score (measure of physical limitations, total symptoms, HRQoL, and social limitations). Summary scores will be examined at each assessment point during follow-up. |
| Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire | Measured at 3, 6, 9 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. |
| Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score | Measured at 3, 6, 9 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. |
Countries
Germany
Outcome results
None listed