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

Study acronym: SOPHIE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoints revised (3)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
LMU Klinikum
20 trials monitored
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Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT07460531
Lead Sponsor LMU Klinikum
Conditions
(from sponsor)		 Heart Failure
Related terms Heart Failure
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov