Actively Recruiting
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Led by Simon Jäger · Updated on 2025-08-22
77
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
Sponsors
S
Simon Jäger
Lead Sponsor
K
Klinikum Nürnberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to validate digital mobility outcomes for monitoring the treatment and disease progression in adult patients with pulmonary hypertension. The main question it aims to answer is: -Do digital mobility outcomes (measured digital endpoints characterizing walking behavior) correlate with measures of precapillary pulmonary pressure as assessed by right heart catheterization? Participants will be asked to wear a small sensor on the lower back for one week at a time for a total of 3 times: at diagnosis and follow-up visits at 3-6 months and again at 6-12 months. Follow-up visits are scheduled by the treating clinician. At the end of the study participants can choose to receive feedback on the sensor measurements.
CONDITIONS
Official Title
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pulmonary hypertension confirmed by right heart catheterization
- Presence of precapillary pulmonary hypertension at recruitment, defined as mean pulmonary arterial pressure (MAP) 20 mmHg, pulmonary arterial wedge pressure (PAWP) 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units
- Follow-up visit scheduled at 3, 6, or 12 months after right heart catheterization
- Independent walking without assistance and 6-minute walking distance greater than 100 meters
- WHO Functional Class I-III
- Ability to provide informed consent and participate in study procedures
- Willingness to wear the Axivity AX6 Sensor for 7 days
You will not qualify if you...
- Hospitalization for a lung disease within 30 days before study recruitment
- Neurological or orthopedic disease limiting walking ability
- Acute pain limiting walking ability
- Poor vision limiting walking ability
- Terminal illness with life expectancy less than 1 year
- Ongoing treatment for cancer
- Acute psychosis or other severe psychiatric illness
- Substance dependence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
2
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Bavaria, Germany, 81377
Actively Recruiting
3
Klinikum Nuremberg
Nuremberg, Bavaria, Germany, 90419
Actively Recruiting
4
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, Germany, 74245
Not Yet Recruiting
Research Team
P
Prof. Dr. med. Simon Jäger
CONTACT
S
Simone Panzer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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