DGK Herztage 2025. Clin Res Cardiol (2025). https://doi.org/10.1007/s00392-025-02737-x
1Kardiologie Praxis Münster Münster, Deutschland; 2Promedi-Kardiologie Frankenthal, Deutschland; 3CardioMed an der Alster Kardiologisch-Internistische Gemeinschaftspraxis Hamburg, Deutschland; 4Cardio Centrum Ludwigsburg Bietigheim Ludwigsburg, Deutschland; 5Praxis im Steiner Thor Straubing, Deutschland; 6Kardiologische Praxis Gera Gera, Deutschland; 7Dr. Richter & Kollegen Essen, Deutschland; 8Kardiologische Praxis Markkleeberg, Deutschland; 9Facharztpraxis für Kardiologie und Innere Medizin Schwäbisch Hall, Deutschland; 10Kardiopraxis Schirmer Kaiserslautern, Deutschland; 11MVZ Drs. Weinrich GmbH Berlin, Deutschland; 12Cardiologicum Dresden Dresden, Deutschland; 13Praxis für Kardiologie Aachen Aachen, Deutschland; 14Medical Department, AstraZeneca GmbH, Hamburg, Germany Hamburg, Deutschland; 15Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland
Background
Standard heart failure (HF) treatment includes sodium-glucose co-transporter 2 inhibitors (SGLT2i), recommended as class IA for HF across all ejection fractions (EF). Patients’ characteristics, -reported outcomes (PRO), and real-world management on the SGLT2i, dapagliflozin are currently being assessed within the EVOLUTION-HF DEallEF (NCT06336330) study.
Methods
EVOLUTION-HF DEallEF is a non-interventional, prospective, longitudinal cohort study, aiming to enrol 1,000 patients with chronic HF in Germany [400 patients with preserved (HFpEF; EF ≥50%), 200 with mildly reduced (HFmrEF; EF 41-49%), and 400 with reduced EF (HFrEF; EF ≤40%)]. Patients aged ≥18, who started dapagliflozin for HF according to EMA approved label within 14-90 days prior to enrolment, are eligible; those with SGLT2i pretreatment are excluded. Standardised PROs are evaluated at baseline and every 3 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medication Adherence Report Scale (MARS), the Patient Health Questionnaire-9 (PHQ-9), and the Work Productivity and Activity Impairment (WPAI). Interim analyses (IA) are planned after 250 and 500 consecutively enrolled patients, as well as at enrolment completion with descriptive statistics for each EF cohort as well as for the total population.
Results
Of 500 patients considered for the 2nd IA (data cutoff: 03/03/2025) 487 met all eligibility criteria and were included in the full analysis set. Selected baseline demographic, clinical characteristics and patient-reported outcome data are shown in the table below.
BMI, body mass index; CFS, clinical frailty scale; NYHA, New York Heart Association; pts, patients; SAQ, Self-Assessment Questionnaire.
Conclusions
Demographic, clinical characteristics, and KCCQ scores from this 2nd IA align with previous data in comparable settings. Depression as concomitant disease was documented in up to 5% of patients. PHQ-9 data at baseline however indicate at least mild depression in over 50% of patients potentially pointing to a higher yet unrecognized disease prevalence. Most patients reported optimal adherence at baseline. As there is a disbalance in enrolment per EF cohort (only 22% HFrEF patients due to exclusion of patients with SGLT2i pretreatment), current data should not yet be used to infer differences between cohorts.