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Clinical Trials in Italy / NCT07460531
Recruiting Observational

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

NCT07460531 · tracked via the Priya Life Science Italy tracker
Sponsor
LMU Klinikum
Phase
Observational
Started
2025-02-01
Last updated
2026-03-11

Condition(s) studied

Heart Failure

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to first heart failure related hospitalization — 3 years
  • Time to death from any cause — 3 years
  • Time to cardiovascular death — 3 years

Trial sites (2)

FacilityCityRegionStatus
LMU University Hospital Munich Bavaria Recruiting
Central Hospital of Bolzano Bolzano Italy Recruiting

More LMU Klinikum trials in Italy

Global Registry and Natural History Study for Mitochondrial Disorders Recruiting
Tendyne European Experience Registry Recruiting
TIRCON International NBIA Registry Recruiting

Other trials for the same condition

Drug Management in Heart Failure Recruiting
RAPIDE: The Feasibility of a Hybrid Care Model Starting soon
A Study on Remote Health Support for Patients With Heart Failure. Starting soon
Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging Recruiting
Electronic Register on Advanced Heart Failure and Transplantation di Cuore Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07460531 on ClinicalTrials.gov ↗ ← All trials in Italy