Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form - Ownership of a pedometer (e.g. smartwatch, activity tracker, smartphone-app, analogical pedometer) Who Should NOT Join This Trial: - Disease or disability that prevents physical activity - Hospitalisation due to heart failure within the last three months Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (2)

LMU University Hospital
Munich, Bavaria, Germany
Central Hospital of Bolzano
Bolzano, Italy