NCT04101630

Activity Monitoring in Pulmonary Hypertension

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Detailed description

A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Activity Monitoring	Monitoring with FitBit

Timeline

• Start date: 2019-10-24
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2019-09-24
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States