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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
: 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
Behavioral: - Activity Monitoring
Monitoring with FitBit
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Vanderbilt University Medical Center
Nashville, Tennessee, 37232