Heart Failure
Conditions
Brief 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.
Interventions
None listed
Sponsors
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first heart failure related hospitalization | 3 years |
| Time to death from any cause | 3 years |
| Time to cardiovascular death | 3 years |
Countries
Germany, Italy
Contacts
CONTACTStefan Brunner, MD
Outcome results
None listed