protocolSection identificationModule nctId: NCT06336330, orgStudyIdInfo id: D1699R00050, briefTitle: Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany, acronym: EvolutionHF-DE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Heart Diseases, conditions: Cardiovascular Diseases, conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time to discontinuation of dapagliflozin, primaryOutcomes measure: Reasons for discontinuation of dapagliflozin, primaryOutcomes measure: Dose changes of dapagliflozin, primaryOutcomes measure: Number of patients with dapagliflozin treatment interruptions, primaryOutcomes measure: Treatment switches from dapagliflozin to other SGLT2i, primaryOutcomes measure: Time to other heart failure treatment discontinuation, primaryOutcomes measure: Number of other heart failure treatment initiation, primaryOutcomes measure: Number of other heart failure treatment dosage changes, primaryOutcomes measure: Number of other heart failure treatment discontinuation, primaryOutcomes measure: Number of glucose lowering medication initiation, primaryOutcomes measure: Number of glucose lowering medication dosage changes, primaryOutcomes measure: Number of glucose lowering medication discontinuation, secondaryOutcomes measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, secondaryOutcomes measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire, secondaryOutcomes measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score, otherOutcomes measure: 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), otherOutcomes measure: Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation, otherOutcomes measure: Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False