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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMU University Hospital, Munich, Bavaria, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time to first heart failure related hospitalization

Time frame: 3 years
Time to death from any cause

Time frame: 3 years
Time to cardiovascular death

Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Brunner, MD

CONTACT

[email protected]

+49 89 4400 0

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: SOPHIE

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2031
First posted: Mar 10, 2026
Registry last updated: Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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