Study of Physical Activity and Heart Health Outcomes in Adults with Chronic Heart Failure

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study called SOPHIE to assess physical activity and cardiovascular outcomes in patients with chronic heart failure. The study aims to enroll 2,000 patients with heart failure, including those with reduced, mildly reduced, or preserved ejection fraction. Participants must have a history of elevated NT-proBNP levels and are monitored to understand how physical activity relates to their health outcomes over time. At the start, participants complete validated physical activity questionnaires such as GPAQ, IPAQ, and KCCQ, and their step counts are tracked for seven days using commercially available pedometer devices like smartwatches, activity trackers, or smartphone apps. Follow-up assessments occur every six months via telephone, where physical activity is reassessed and cardiovascular events, hospitalizations, and patient-reported outcomes are recorded. Participants are involved for at least three years, during which researchers measure the time to first heart failure-related hospitalization, time to death from any cause, and time to cardiovascular death. The study relies on self-reported data, pedometer measurements, and telephone follow-ups to monitor health status and physical activity, aiming to gather insights into how activity levels impact heart failure progression and outcomes.

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