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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
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| Measure | Description | Time Frame |
|---|---|---|
| Time to dapagliflozin treatment discontinuation | Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason. | 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. | 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. | Baseline to 12 months |
| Number of dapagliflozin treatment changes | The number of participants who switch to another HF medication other than dapagliflozin. | Baseline to 12 months |
| Percentage of dapagliflozin treatment changes | The percentage of participants who switch to another HF medication other than dapagliflozin. | Baseline to 12 months |
| Number of dapagliflozin treatment discontinuation | The number of participants who discontinued treatment with dapagliflozin. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Reading | Berkshire | RG1 5AN | United Kingdom | ||
| Research Site |
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| Label | URL |
|---|---|
| redacted CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Percentage of dapagliflozin treatment discontinuation |
The percentage of participants who discontinued treatment with dapagliflozin. |
| 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. | Baseline to 12 months |
| Number of other heart failure treatment initiation | The number of participants who initiate new heart failure medication other than dapagliflozin. | Baseline to 12 months |
| Percentage of other heart failure treatment initiation | The percentage of participants who initiate new heart failure medication other than dapagliflozin. | 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. | 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. | 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. | 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. | 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. | Baseline to 12 months |
| Number of glucose lowering medication initiation | The number of participants who initiate new glucose lowering medication other than dapagliflozin. | Baseline to 12 months |
| Percentage of glucose lowering medication initiation | The percentage of participants who initiate new glucose lowering medication other than dapagliflozin. | 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. | 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. | Baseline to 12 months |
| Number of glucose lowering medication discontinuation | The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin. | Baseline to 12 months |
| Percentage of glucose lowering medication discontinuation | The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin. | Baseline to 12 months |
| 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. | 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. | Measured at 3, 6, 9 and 12 months |
| Truro |
| Cornwall |
| TR1 3LJ |
| United Kingdom |
| Research Site | Portadown | County Armagh | BT63 5QQ | United Kingdom |
| Research Site | Barnstaple | Devon | EX31 4JB | United Kingdom |
| Research Site | Westcliff-on-Sea | Essex | SS0 0RY | United Kingdom |
| Research Site | Port Talbot | Glamorgan | SA12 7BR | United Kingdom |
| Research Site | London | Greater London | SE5 9RS | United Kingdom |
| Research Site | Stoke-on-Trent | Staffordshire | AT4 6QG | United Kingdom |
| Research Site | Brighton | Sussex | BN2 5BE | United Kingdom |
| Research Site | Coventry | Warwickshire | CV2 2DX | United Kingdom |