NCT04451850

HRV as a Marker of Treatment Response in PAH Arterial Hypertension

Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	Noninvasive actigraphy monitor	Noninvasive chest-mounted actigraphic device to be worn for 2 hour intervals two times per week during the six month study participation.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-06-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States