NCT04451850Completed
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)
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 25 Jun 2020
- Start date
- 1 Jun 2021
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- University of Cincinnati
- NCT number
- NCT04451850
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From 1 Jun 2021 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Currently being on targeted PAH therapy at the time of consent and enrollment
Other illness
- 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
Lab values
- 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
Other
- Inability to undergo (non-contrast) Magnetic Resonance Imaging (MRI) testing
- Inability to complete a six-minute walk test
- Unable to consent, pregnant women, and prisoners.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.