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Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
RECRUITINGSponsored by LMU Klinikum
Actively Recruiting
SponsorLMU Klinikum
Started2025-02-01
Est. completion2030-12-31
Eligibility
Age18 Years+
View on ClinicalTrials.gov →
NCT07460531
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.
Eligibility
Age: 18 Years+
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
Conditions2
Heart DiseaseHeart Failure
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Actively Recruiting
SponsorLMU Klinikum
Started2025-02-01
Est. completion2030-12-31
Eligibility
Age18 Years+
View on ClinicalTrials.gov →
NCT07460531