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Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure | Clinical Trials | Clareo Health

RECRUITING

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

NCT07460531•LMU Klinikum

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

LMU University Hospital

Munich, Bavaria, Germany

Central Hospital of Bolzano

Bolzano, Italy

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 31, 2030

Completion Date

June 30, 2031

Last Updated

March 11, 2026

Enrollment

2,000

ESTIMATED participants

Conditions

Heart Failure

Contacts

Stefan Brunner, MD

CONTACT

+49 89 4400 0 Stefan.Brunner@med.uni-muenchen.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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