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OpenTrials
Completed

NCT Number: NCT05350202

Emp-Activity: Empagliflozin Functional Capacity

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Mircheva, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

Empagliflozin was administered according to the approved product information.

Other names: Jardiance®

Primary outcomes

  1. 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.

    Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as [Week 24] - [Baseline]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.

Secondary outcomes

  1. Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin

    Time frame: At baseline and at Week 24.

    This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort.

  2. Number of Participants With Comorbidities

    Time frame: At baseline.

    Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.

  3. Number of Participants With Concomitant Heart-failure (HF) Related Medication

    Time frame: At baseline.

    Number of patients who took concomitant HF-related medication.

  4. Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline

    Time frame: Up to 6 months prior to baseline visit.

    Number of patients hospitalized at least one time due to heart failure (HF).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Empagliflozin Functional Capacity - Non-Interventional Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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