Status:
COMPLETED
Emp-Activity: Empagliflozin Functional Capacity
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
3431 Patients enrolled
Trial Details
Trial ID
NCT05350202
Start Date
December 18 2022
End Date
July 25 2024
Last Update
August 26 2025
Active Locations (350)
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1
Dr. Mircheva
Burgas, Bulgaria, 8000
2
Dr. Yordanov
Haskovo, Bulgaria, 6304
3
MBAL Atanas Dafovski, Kardzhali
Kardzhali, Bulgaria, 6600
4
Dr. Krasteva
Kyustendil, Bulgaria, 2501