Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05350202
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to study participation
* Male and female patients ≥ 18 years at Visit 1
* Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel
* Patients with diagnosis of chronic heart failure NYHA Class 2-4
* Treatment-naïve for SGLT2i at visit 1
* Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s)
Exclusion Criteria:
* Missing physician's diagnosis of chronic heart failure
* Patients hospitalized at visit 1
* Life expectancy ≤ 12 months according to physician's assessment
* Lack of informed consent
* Pregnant or lactating females
* Participation in a parallel interventional clinical trial
* Chosen treatment with another SGLT2i drug than empagliflozin
* Having been enrolled into the non-empagliflozin-arm of this non-interventional study
* Current or prior treatment with SGLT2i at visit 1
* Patients with contraindications according to current Summary of Product Characteristics (SmPC)
* Patients with dependency or relationship to the treating physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05350202
Study Brief:
Protocol Section:
NCT05350202