NCT07460531Recruiting
Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- LMU Klinikum
- Diseases
- Heart failure
- NCT number
- NCT07460531
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Feb 2025 to the primary completion date, 31 Dec 2030
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disease or disability that prevents physical activity
- Hospitalisation due to heart failure within the last three months
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LMU University Hospital Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Central Hospital Of Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.