Daily activity and heart outcomes in people with chronic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SOPHIE is a prospective, multicentre observational cohort enrolling 2,000 adults with chronic heart failure. At baseline participants complete validated physical activity questionnaires (GPAQ, IPAQ, KCCQ) and provide seven-day step counts from consumer pedometers or wearable devices. Follow-up occurs every six months by telephone to repeat activity assessments and to record cardiovascular events, hospitalisations, and patient-reported outcomes. Inclusion requires prior NT-proBNP >600 pg/ml, NYHA II–IV status across any ejection fraction category, age ≥18, and ownership of a pedometer, while exclusion includes conditions preventing activity or heart-failure hospitalization within the last three months.

Why it matters

Who can join: the full rules

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

Where it's running

• LMU University Hospital
  Munich, Bavaria, Germany Recruiting
• Central Hospital of Bolzano
  Bolzano, Italy Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.