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Completed

NCT Number: NCT04451850

HRV as a Marker of Treatment Response in PAH Arterial Hypertension

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Other names: Polar H10 Heart Rate Monitor

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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