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

LMU Klinikum2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

RECRUITING

Central Hospital of Bolzano

Bolzano, Italy

RECRUITING

Outcomes

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

Central Contacts

Stefan Brunner, MD

CONTACT

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

Data from ClinicalTrials.gov

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