Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-07 @ 11:02 PM
Study NCT ID:
NCT07137260
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Sponsor:
Simon Jäger
Organization:
Study Overview
Official Title:
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
-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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: