Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom.

Heart Failure Clinical Trial

— EVOLUTION-HF  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05188144
• Other study ID #: D169CR00001
• Status: Active, not recruiting
• Start date: November 29, 2021
• Est. completion date: March 2, 2024

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 239
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Research Site	Barnstaple	Devon
United Kingdom	Research Site	Brighton	Sussex
United Kingdom	Research Site	Coventry	Warwickshire
United Kingdom	Research Site	London	Greater London
United Kingdom	Research Site	Port Talbot	Glamorgan
United Kingdom	Research Site	Portadown	County Armagh
United Kingdom	Research Site	Reading	Berkshire
United Kingdom	Research Site	Stoke-on-Trent	Staffordshire
United Kingdom	Research Site	Truro	Cornwall
United Kingdom	Research Site	Westcliff on Sea	Essex

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of dapagliflozin treatment changes	The number of participants who switch to another HF medication other than dapagliflozin.	Baseline to 12 months
Primary	Percentage of dapagliflozin treatment changes	The percentage of participants who switch to another HF medication other than dapagliflozin.	Baseline to 12 months
Primary	Number of dapagliflozin treatment discontinuation	The number of participants who discontinued treatment with dapagliflozin.	Baseline to 12 months
Primary	Percentage of dapagliflozin treatment discontinuation	The percentage of participants who discontinued treatment with dapagliflozin.	Baseline to 12 months
Primary	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
Primary	Number of other heart failure treatment initiation	The number of participants who initiate new heart failure medication other than dapagliflozin.	Baseline to 12 months
Primary	Percentage of other heart failure treatment initiation	The percentage of participants who initiate new heart failure medication other than dapagliflozin.	Baseline to 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of glucose lowering medication initiation	The number of participants who initiate new glucose lowering medication other than dapagliflozin.	Baseline to 12 months
Primary	Percentage of glucose lowering medication initiation	The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.	Baseline to 12 months
Primary	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
Primary	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
Primary	Number of glucose lowering medication discontinuation	The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.	Baseline to 12 months
Primary	Percentage of glucose lowering medication discontinuation	The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.	Baseline to 12 months
Secondary	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.	Measured at 3, 6, 9 and 12 months
Secondary	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
Secondary	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