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

Recruiting now

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT07460531

Run by

LMU Klinikum

People needed

2000

Starts

2025-02-01

Expected to finish

2031-06-30

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Disease or disability that prevents physical activity
• Hospitalisation due to heart failure within the last three months

Where it is running

• LMU University Hospital — Munich, Bavaria, Germany (enrolling)
• Central Hospital of Bolzano — Bolzano, Italy (enrolling)

Full record on ClinicalTrials.gov

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