NCT07460531

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
63mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2025Jun 2031

Study Start

First participant enrolled

February 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5.9 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Time to first heart failure related hospitalization

    3 years

  • Time to death from any cause

    3 years

  • Time to cardiovascular death

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating hospitals

You may qualify if:

  • 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)

You may not qualify if:

  • Disease or disability that prevents physical activity
  • Hospitalisation due to heart failure within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LMU University Hospital

Munich, Bavaria, 80336, Germany

RECRUITING

Central Hospital of Bolzano

Bolzano, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Stefan Brunner, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

IT(1)DE(1)