Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
Recruiting · NCT07460531 · Observational (researchers observe without assigning treatment) · Lead sponsor: LMU Klinikum
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Central Hospital of Bolzano - Bolzano, Italy
- LMU University Hospital - Munich, Bavaria, Germany