Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Time to first heart failure related hospitalization [Time frame: 3 years]
- Time to death from any cause [Time frame: 3 years]
- Time to cardiovascular death [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- LMU University Hospital — Munich
Italy · 1 center
- Central Hospital of Bolzano — Bolzano
Identifiers
NCT: NCT07460531 · 24-0820