HRV as a Marker of Treatment Response in PAH Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT04451850|
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 1, 2021
|Condition or disease||Intervention/treatment|
|Pulmonary Arterial Hypertension||Other: Noninvasive actigraphy monitor|
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.
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
- 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.Other Name: Polar H10 Heart Rate Monitor
- Change from baseline in HRV via RMSSD [ Time Frame: 6 months ]Change from baseline in Root Mean Squared Successive Differences (RMSSD) measure of Heart Rate variability in patients on targeted therapy
- Change from baseline in HRV via SDNN [ Time Frame: 6 months ]Change from baseline in Standard Deviation of N-to-N (SDNN) measure of Heart Rate Variability in patients on targeted therapy
- Correlation with Cardiac Magnetic Resonance Imaging Variables [ Time Frame: 6 months ]Correlation between RMSSD and SDNN with key cardiac Magnetic Resonance Imaging Variables of PAH disease, the Right Ventricular Stroke Volume
- Correlation with NTproBNP [ Time Frame: 6 months ]Correlation between RMSSD and SDNN with N-terminal Pro-B-Type Natriuretic Peptide (NTproBNP), a marker of PAH disease severity and treatment response
- Correlation with REVEAL 2.0 Risk Score [ Time Frame: 6 months ]Correlation between RMSSD and SDNN with the REVEAL 2.0 Risk score, a measure of PAH prognosis
- Correlation with CAMPHOR Quality of Life Score [ Time Frame: 6 months ]Correlation between RMSSD and SDNN with the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) score, a 3-domain quality of life assessment tool specific to PAH patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451850
|Contact: Susan McMahan, BSN, RN, CCRPfirstname.lastname@example.org|
|Principal Investigator:||Arun Jose, MD, MS||University of Cincinnati|