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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Stefan Brunner, MD; Phone Number: +49 89 4400 0; Email: Stefan.Brunner@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Recruiting
      • LMU University Hospital
      • Contact: Brunner, MD; Phone Number: +49 89 4400 0; Email: Stefan.Brunner@med.uni-muenchen.de
• Italy
  • Bolzano, Italy
    • Recruiting
    • Central Hospital of Bolzano
    • Contact: Matthias Unterhuber, MD; Phone Number: +39 0471 439 950; Email: kardiologie.bz@sabes.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participating hospitals

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to cardiovascular death	3 years
Time to first heart failure related hospitalization	3 years
Time to death from any cause	3 years

Collaborators and Investigators

• Sponsor: LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 24-0820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No