Emp-Activity: Empagliflozin Functional Capacity

Sponsor
Boehringer Ingelheim
Study ID
NCT05350202
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin was administered according to the approved product information.

Study Details

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.

Key Dates

Start date
Dec 18, 2022
Status verified
Aug 2025
Primary completion
Jul 25, 2024
Completion
Jul 25, 2024

Study Design

Enrollment
3,431 participants (actual)

Arms

  • Arm: Empagliflozin-treated patients
    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).
  • Arm: Non-SGLT2i-treated patients
    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.

Primary Outcome Measure

Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice [ Time Frame: At baseline and at week 24. ]

Related coverage on Hipa.ai

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