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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 Polarâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive actigraphy monitor | Other | Noninvasive chest-mounted actigraphic device to be worn for 2 hour intervals two times per week during the six month study participation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HRV via RMSSD | Change from baseline in Root Mean Squared Successive Differences (RMSSD) measure of Heart Rate variability in patients on targeted therapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HRV via SDNN | Change from baseline in Standard Deviation of N-to-N (SDNN) measure of Heart Rate Variability in patients on targeted therapy | 6 months |
| Correlation with Cardiac Magnetic Resonance Imaging Variables |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen at the University of Cincinnati PAH Clinic in Cincinnati, Ohio
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| Name | Affiliation | Role |
|---|---|---|
| Arun Jose, MD, MS | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21531951 | Background | Heresi GA, Dweik RA. Strengths and limitations of the six-minute-walk test: a model biomarker study in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 May 1;183(9):1122-4. doi: 10.1164/rccm.201012-2079ED. No abstract available. | |
| 23234873 | Background | Ulrich S, Fischler M, Speich R, Bloch KE. Wrist actigraphy predicts outcome in patients with pulmonary hypertension. Respiration. 2013;86(1):45-51. doi: 10.1159/000342351. Epub 2012 Dec 11. |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Correlation between RMSSD and SDNN with key cardiac Magnetic Resonance Imaging Variables of PAH disease, the Right Ventricular Stroke Volume
| 6 months |
| Correlation with NTproBNP | Correlation between RMSSD and SDNN with N-terminal Pro-B-Type Natriuretic Peptide (NTproBNP), a marker of PAH disease severity and treatment response | 6 months |
| Correlation with REVEAL 2.0 Risk Score | Correlation between RMSSD and SDNN with the REVEAL 2.0 Risk score, a measure of PAH prognosis | 6 months |
| Correlation with CAMPHOR Quality of Life Score | 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 | 6 months |
| 22576635 | Background | Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150. |