Activity Monitoring in Pulmonary Hypertension
1 other identifier
observational
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
September 26, 2025
September 1, 2025
8.1 years
September 16, 2019
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Activity Monitoring
Participants will wear an accelerometer to record activity level
Baseline
Activity Monitoring
Participants will wear an accelerometer to record activity level
1 year
Activity Monitoring
Participants will wear an accelerometer to record activity level
2 year
Activity Monitoring
Participants will wear an accelerometer to record activity level
3 year
Secondary Outcomes (5)
Six Minute Walk Distance (6MWD) Test
Baseline, 1 year, 2 year, 3 year
Intensity of Activity
Baseline, 1 year, 2 year, 3 year
Quality of Life 36-Item Short Form Survey (SF-36)
Baseline, 1 year, 2 year, 3 year
emPHasis-10
Baseline, 1 year, 2 year, 3 year
Minnesota Living with Heart Failure (MLHF)
Baseline, 1 year, 2 year, 3 year
Study Arms (2)
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.
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.
Interventions
Monitoring with FitBit
Eligibility Criteria
Participants will be those enrolled in the Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS) and any patient with pulmonary hypertension.
You may qualify if:
- Enrolled in L-PVDOMICS or
- Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis
You may not qualify if:
- Pregnancy
- Hospitalization within the prior 3 months
- Orthopedic limitations that preclude 6MWD testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan L Brittain, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 24, 2019
Study Start
October 24, 2019
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
September 26, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- at the end of the PVDOMICS study
- Access Criteria
- subject to approval of PVDOMICS Steering Committee
Use of study data and biospecimens, and resulting findings, during the PVDOMICS study are subject to approval of the PVDOMICS Steering Committee and follow guidelines of the Publications and Ancillary Study Committee. The data and biospecimens from subjects at a clinical center are the property of the PVDOMICS study and are under the custody of that center. At the end of the PVDOMICS study and this proposal, the data and remaining biospecimens will be transferred to PVDOMICS and/or to the National Heart, Lung and Blood Institute (NHLBI) Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) biobank and become the property of one of these organizations. Future researchers may request data or biospecimens from a biobank with approval following the guidelines of the biobank. Protocols for data sharing after the conclusion of PVDOMICS have not been established, but will be created in accordance with the NIH Data Sharing Policy.