Clinical trial NCT06336330: Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany
Official title: Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Cardiovascular Diseases
Heart Failure
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received treatment with dapagliflozin for HF since 14-90 day before entering the study will be eligible for enrolment by either primary or secondary care healthcare professionals from outpatient settings. All treatment decisions (i.e., dose and duration of treatment) will be at the discretion of the patient's healthcare provider. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 days and ≤90 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. Patients will only be enrolled after they have given consent to participate in the study. It is at the discretion of the physician whether or not to initiate patients on treatment with dapagliflozin and enrol them in the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to discontinuation of dapagliflozin
timeFrame: Baseline to 12 months
measure: Reasons for discontinuation of dapagliflozin
timeFrame: Baseline to 12 months
measure: Dose changes of dapagliflozin
timeFrame: Baseline to 12 months
measure: Number of patients with dapagliflozin treatment interruptions
timeFrame: Baseline to 12 month
measure: Treatment switches from dapagliflozin to other SGLT2i
timeFrame: Baseline to 12 months
measure: Time to other heart failure treatment discontinuation
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment initiation
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment dosage changes
timeFrame: Baseline to 12 months
measure: Number of other heart failure treatment discontinuation
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication initiation
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication dosage changes
timeFrame: Baseline to 12 months
measure: Number of glucose lowering medication discontinuation
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: Measured at 3, 6, 9 and 12 months
measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
timeFrame: Measured at 3, 6, 9 and 12 months
measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score
timeFrame: Measured at 3, 6, 9 and 12 months
Other outcomes:
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)
timeFrame: Measured at 3, 6, 9 and 12 months
measure: Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation
timeFrame: Measured at 3, 6, 9 and 12 months
measure: Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation
timeFrame: Measured at 3, 6, 9 and 12 months
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Alsfeld
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Bechhofen
country: Germany
facility: Research Site
city: Bergisch Gladbach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Brilon
country: Germany
facility: Research Site
city: Bruchsal
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Dinslaken
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankenthal
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hoppegarten
country: Germany
facility: Research Site
city: Kaiserslautern
country: Germany
facility: Research Site
city: Kitzingen
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Ludwigshafen am Rhein
country: Germany
facility: Research Site
city: M Hldorf
country: Germany
facility: Research Site
city: M Nster
country: Germany
facility: Research Site
city: Markkleeberg
country: Germany
facility: Research Site
city: Meiningen
country: Germany
facility: Research Site
city: N Rnberg
country: Germany
facility: Research Site
city: Naumburg
country: Germany
facility: Research Site
city: Oschersleben
country: Germany
facility: Research Site
city: Papenburg
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Querfurt
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Schw Bisch Hall
country: Germany
facility: Research Site
city: Schwandorf
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Steinfurt
country: Germany
facility: Research Site
city: Stollberg
country: Germany
facility: Research Site
city: Straubing
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Wermsdorf
country: Germany
facility: Research Site
Study officials:
References: