Activity Monitoring in Pulmonary Hypertension

NCT ID: NCT04101630

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2028-01-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Pulmonary Hypertension

Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires \[emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys\], medication changes, hospitalization, and death.

Activity Monitoring

Intervention Type: BEHAVIORAL

Monitoring with FitBit

Healthy Volunteers

Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires \[emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys\], medication changes, hospitalization, and death.

Activity Monitoring

Intervention Type: BEHAVIORAL

Monitoring with FitBit

Interventions

Activity Monitoring

Monitoring with FitBit

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in L-PVDOMICS or
• Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion Criteria

• Pregnancy
• Hospitalization within the prior 3 months
• Orthopedic limitations that preclude 6MWD testing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Evan Brittain

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan L Brittain, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Physical Activity in PH

Identifier Type: -

Identifier Source: org_study_id