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Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure

Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure

Recruiting
18 years and older
All
Phase N/A

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Overview

SOPHIE is a prospective, multicentre, observational cohort study aiming to enrol 2,000 CHF patients. Baseline assessments include validated PA questionnaires (GPAQ, IPAQ, KCCQ) and seven-day step counts from commercially available pedometer devices. Follow-up is conducted every six months via telephone, repeating PA assessments and recording cardiovascular events, hospitalisations, and patient-reported outcomes.

Eligibility

Inclusion Criteria:

  • Heart failure NT-proBNP \>600 pg/ml (at least once in the history) NYHA-Class II-IV HFrEF - heart failure with reduced ejection fraction; LVEF ≤40% or HFmrEF - heart failure with mildly reduced ejection fraction; LVEF 41% - 49% or HFpEF - heart failure with preserved ejection fraction; LVEF ≥50%
  • Age ≥18 years old
  • Willingness to participate in the study, confirmed by a signed informed consent form
  • Ownership of a pedometer (e.g. smartwatch, activity tracker, smartphone-app, analogical pedometer)

Exclusion Criteria:

  • Disease or disability that prevents physical activity
  • Hospitalisation due to heart failure within the last three months

Study details
    Heart Failure

NCT07460531

LMU Klinikum

13 May 2026

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