Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany

Heart Failure Clinical Trial

— EvolutionHF-DE  

Official title:

Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336330
• Other study ID #: D1699R00050
• Status: Recruiting
• Start date: April 25, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

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 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Chemnitz
Germany	Research Site	Gera
Germany	Research Site	Hamburg
Germany	Research Site	Ludwigsburg
Germany	Research Site	Meiningen
Germany	Research Site	Mühldorf
Germany	Research Site	Münster
Germany	Research Site	Nürnberg
Germany	Research Site	Passau
Germany	Research Site	Pirna
Germany	Research Site	Rostock
Germany	Research Site	Schwandorf
Germany	Research Site	Siegen
Germany	Research Site	Steinfurt
Germany	Research Site	Straubing
Germany	Research Site	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The absolute change from baseline in occurrence of depressions in patients initiated on dapagliflozin for HF as captured by the Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 comprises 9 items that capture depressed mood and anhedonia. It has been validated as a screening tool with good evidence of responsiveness. The PHQ-9 score is obtained by adding the score for each question (total points). PHQ-9 score =10 showed a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 have been shown to represent mild, moderate, moderately severe, and severe depression, respectively.	Measured at 3, 6, 9 and 12 months
Other	Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation	The number of patients hospitalised will be examined at each assessment point.	Measured at 3, 6, 9 and 12 months
Other	Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation	Duration of outpatient clinic visits in days, will be examined at each assessment point.	Measured at 3, 6, 9 and 12 months
Primary	Time to discontinuation of dapagliflozin	Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason (from the perspective of the prescriber).	Baseline to 12 months
Primary	Reasons for discontinuation of dapagliflozin	Reasons for discontinuation (from the perspective of the prescriber) of patients initiated on dapagliflozin for HF will be described.	Baseline to 12 months
Primary	Dose changes of dapagliflozin	The number of participants with doses changes for dapagliflozin	Baseline to 12 months
Primary	Number of patients with dapagliflozin treatment interruptions	The number of participants who discontinue treatment with dapagliflozin.	Baseline to 12 month
Primary	Treatment switches from dapagliflozin to other SGLT2i	The number of participants who switch from dapagliflozin to another SGLT2i (Sodium-glucose cotransporter-2 inhibitor) treatment for HF.	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	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	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	Number of glucose lowering medication initiation	The number 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	Number of glucose lowering medication discontinuation	The number 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. 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.	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