https://doi.org/10.1007/s00392-024-02526-y
1UKM Marienhospital Steinfurt Klinik für Kardiologie Steinfurt, Deutschland; 2Cardio Centrum Ludwigsburg Bietigheim Ludwigsburg, Deutschland; 3CardioMed an der Alster Kardiologisch-Internistische Gemeinschaftspraxis Hamburg, Deutschland; 4Promedi-Kardiologie Frankenthal, Deutschland; 5AstraZeneca GmbH Medical Deparment Hamburg, Deutschland; 6AstraZeneca GmbH Medical Evidence Hamburg, Deutschland; 7Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland
Background
In 2020, the sodium-glucose cotransporter-2 inhibitor (SGLT2i) dapagliflozin received approval for symptomatic chronic heart failure (HF) treatment in patients with reduced left ventricular ejection fraction (HFrEF). Results from the randomised controlled DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure) led to the approval of a label extension to symptomatic chronic HF patients with mildly reduced (HFmrEF) and preserved ejection fraction (HFpEF) by the European Commission on February 6th, 2023. However, real world evidence about HF symptoms and their impact on individual physical capacity, health-related quality of life (HRQoL) and work productivity, as well as health care utilization of HF patients treated with dapagliflozin alongside with the investigation of HF treatment patterns in Germany is still missing.
Purpose
The purpose of this study is to provide early insights into and evaluate real-world clinical and patient-reported outcome (PRO) data as well as health care utilisation in adult patients who are newly initiated on dapagliflozin treatment for symptomatic chronic HF (HFrEF, HFpEF, and HFmrEF) in accordance with current guidelines and approved HF label. Here we present the study design.
Methods
The non-interventional, prospective, longitudinal cohort study EVOLUTION HF DEallEF (NCT06336330) is planned to be conducted in up to 100 cardiology practices and clinics in Germany from 2024 to 2026. Adult patients with HFrEF, HFmrEF, or HFpEF in whom dapagliflozin was initiated 14 to 90 days prior enrolment will be invited to participate. Criteria for non-participation include type 1 diabetes or former SGLT2i treatment. Data are documented every three months over one year. Primary outcome measures are baseline demographics and clinical characteristics of patients with newly prescribed dapagliflozin for HF treatment, dapagliflozin treatment patterns, including time to and reasons for discontinuation, as well as other HF and glucose lowering medication treatment patterns over time. Secondary outcome measures include PROs captured by the Kansas City Cardiomyopathy Questionnaire, Medical Adherence Report Scale, and Work Productivity and Impairment questionnaire. Additional exploratory outcome measures include occurrence of depression as assessed by the Patient Health Questionnaire-9, the degree of health care utilisation, and patient-reported lifestyle, needs, expectations and satisfaction with medical care. The planned sample size is 1.000 patients. The three different EF cohorts (HFpEF, HFmrEF, HFrEF) will be analysed separately and within cohorts as subgroups of interest (e.g., gender, age, guideline-directed medical therapy) using descriptive statistics.
First patient was enrolled on April 26th, 2024, and last patient out is expected in September 2026. Recruitment is ongoing through September 2025.
This study is sponsored by AstraZeneca, supported by BNK.