Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLMU Klinikum
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Disease or disability that prevents physical activity
Hospitalisation due to heart failure within the last three months
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov