NCT07460531 Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure
| NCT ID | NCT07460531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LMU Klinikum |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2025-02-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07460531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07460531 currently recruiting?
Yes, NCT07460531 is actively recruiting participants. Contact the research team at Stefan.Brunner@med.uni-muenchen.de for enrollment information.
Where is the NCT07460531 trial being conducted?
This trial is being conducted at Munich, Germany, Bolzano, Italy.
Who is sponsoring the NCT07460531 clinical trial?
NCT07460531 is sponsored by LMU Klinikum. The trial plans to enroll 2,000 participants.
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