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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.