RecruitingNCT07460531

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

Sponsor

LMU Klinikum

Enrollment

2,000 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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)