Status:
COMPLETED
HRV as a Marker of Treatment Response in PAH Arterial Hypertension
Lead Sponsor:
University of Cincinnati
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-70 years
Brief 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 pat...
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 v...
Eligibility Criteria
Inclusion
- All adult patients (ages 18-70) of any functional class with a new diagnosis of PAH (World health Organization Group 1) placed on targeted therapy
- Eligible PAH etiologies include idiopathic PAH, associated with connective tissue disease, human immunodeficiency virus, hereditary, or portopulmonary hypertension
- Right heart catheterization (RHC) hemodynamics with a mean pulmonary arterial pressure \>=20 millimetres of mercury at rest, a pulmonary capillary wedge pressure \<= 15 millimetres of mercury, and a pulmonary vascular resistance \>= 3 woods units
Exclusion
- Inability to undergo (non-contrast) Magnetic Resonance Imaging (MRI) testing
- On chronotropic agents (Beta-Blockers, anti-arrhythmic medications, etc.) that could affect the calculation and interpretation of HRV measures
- Conditions that could affect the accuracy of MRI imaging, including a history previously repaired or unrepaired congenital heart defects, ventricular or atrial septal defects, or other anatomic cardiac abnormalities)
- Inability to complete a six-minute walk test
- Currently being on targeted PAH therapy at the time of consent and enrollment
- Thyroid disease, known arrhythmias in the past six months, uncontrolled anemia with a hemoglobin less than 7 grams per deciliter, untreated coronary artery disease or a diagnosis of myocardial infarction in the past 6 months, the presence of a cardiac pacemaker
- Clinically significant lung disease (including pulmonary function testing forced vital capacity \< 60%), a positive ventilation/perfusion scan, uncontrolled sleep apnea not adherent with noninvasive positive pressure ventilation
- Unable to consent, pregnant women, and prisoners.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04451850
Start Date
June 1 2021
End Date
December 1 2024
Last Update
March 30 2025
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267