Emp-Activity: Empagliflozin Functional Capacity

Boehringer Ingelheim

Status: Completed

Conditions: Heart Failure

Treatments: Drug: Empagliflozin

Study type: Observational

Funder types: Industry

Identifiers

NCT05350202

1245-0259

Details and patient eligibility

About

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: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.

Enrollment: 3,431 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,431 participants in 2 patient groups

Empagliflozin-treated patients

Description:

Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).

Treatment:

Drug: Empagliflozin

Non-SGLT2i-treated patients

Description:

Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.