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
This trial does not accept healthy volunteersQualifiers
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 population
Participating hospitals
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Time to first heart failure related hospitalization
Time frame
3 years2
Time to death from any cause
Time frame
3 years3
Time to cardiovascular death
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov