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Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)
This is a prospective longitudinal cohort study to determine the value of HRV obtained using noninvasive actigraphy to quantify the response to pulmonary vasodilator therapy in newly diagnosed PAH patients
This single center prospective longitudinal cohort study will take place at the University of Cincinnati (UC). We will screen adult patients newly diagnosed with PAH and placed on targeted pulmonary vasodilator therapy by their treating physician for enrollment. We will enroll 35 eligible participants over a two-year period. HRV will be measured using the Polar™ H10 wearable chest actigraphy device in conjunction with analytic software to capture HRV data. After enrollment and completion of the baseline visit, study participants will receive chest actigraphy device to measure their heart rate for a two hour period twice a week during study participation. Follow up research visits will be conducted at one-month, 3-months, and 6-months to sync the actigraphy device and assess any AE's. In-between these visits, study staff will communicate with participants at two weeks, two months, 4 months, and 5 months, to identify and address any issues with study actigraphic device, assess any adverse events and maintain regular contact with study participants. Throughout study participation, subjects will continue routine clinical care at the direction of their treating physician as needed.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
University of Cincinnati
Cincinnati, Ohio, United States
Start Date
June 1, 2021
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
March 30, 2025
24
ACTUAL participants
Noninvasive actigraphy monitor
OTHER
Lead Sponsor
University of Cincinnati
NCT07218029
NCT06649110
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06481852