A research team at Vanderbilt University Medical Center has begun a trial to compare the value of tracking daily activity and the Six Minute Walk Distance to predict pulmonary hypertension prognosis. The Longitudinal Pulmonary Vascular Disease Phenomics Program (L-PVDOMICS), a prospective, longitudinal, observational study will track daily activity and patient-reported outcomes in participants enrolled. Patients with pulmonary hypertension and healthy participants will undergo activity monitoring for 12 weeks once a year for 4 years. Metrics will include patient-reported outcomes including quality of life (emphasis-10, Minnesota Living with Heart Failure, and SF-36 surveys), medication changes, hospitalization, and death.
The study is designed to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity. Five hundred patients are expected to enroll and the estimated closing date is June 2023. The hypothesis for the study is that daily activity will have stronger prognostic value after 12 weeks than the Six Minute Walk Distance in patients with pulmonary hypertension. Participants will wear an accelerometer to record activity level to determine daily activities and will also engage in the Six Minute Walk Distance Test.
Individuals that are pregnant or have been hospitalized within the past 3 months will be excluded. Participants are currently being recruited.
The trial sponsor is Vanderbilt University Medical Center.