Daily activity and heart outcomes in people with chronic heart failure
Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
We test whether tracking daily activity with pedometers and questionnaires can help predict heart-related events and hospital visits in adults with chronic heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 2 sites (Munich, Bavaria and 1 other locations) |
| Trial ID | NCT07460531 on ClinicalTrials.gov |
What this trial studies
SOPHIE is a prospective, multicentre observational cohort enrolling 2,000 adults with chronic heart failure. At baseline participants complete validated physical activity questionnaires (GPAQ, IPAQ, KCCQ) and provide seven-day step counts from consumer pedometers or wearable devices. Follow-up occurs every six months by telephone to repeat activity assessments and to record cardiovascular events, hospitalisations, and patient-reported outcomes. Inclusion requires prior NT-proBNP >600 pg/ml, NYHA II–IV status across any ejection fraction category, age ≥18, and ownership of a pedometer, while exclusion includes conditions preventing activity or heart-failure hospitalization within the last three months.
Who should consider this trial
Good fit: Adults with chronic heart failure (NYHA II–IV) who have had NT‑proBNP >600 pg/ml, own a pedometer or activity device, and are physically able to walk would be ideal candidates.
Not a fit: Patients who cannot ambulate, lack a pedometer or reliable phone access, or who were hospitalized for heart failure within the past three months are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could help clinicians identify higher-risk patients earlier and support activity-based monitoring to reduce hospitalisations.
How similar studies have performed: Previous observational studies have linked wearable activity measures and questionnaire scores to outcomes in heart failure, but large prospective cohorts using consumer pedometers remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Munich, Bavaria and 1 other locations
- LMU University Hospital — Munich, Bavaria, Germany (Recruiting)
- Central Hospital of Bolzano — Bolzano, Italy (Recruiting)
Study contacts
- Study coordinator: Stefan Brunner, MD
- Email: Stefan.Brunner@med.uni-muenchen.de
- Phone: +49 89 4400 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.