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HRV as a Marker of Treatment Response in PAH Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT04451850
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 1, 2021
Information provided by (Responsible Party):
Arun Jose, University of Cincinnati

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 patients

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: Noninvasive actigraphy monitor

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 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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Intervention Details:
  • Other: Noninvasive actigraphy monitor
    Noninvasive chest-mounted actigraphic device to be worn for 2 hour intervals two times per week during the six month study participation.
    Other Name: Polar H10 Heart Rate Monitor

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at the University of Cincinnati PAH Clinic in Cincinnati, Ohio

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451850

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Contact: Susan McMahan, BSN, RN, CCRP 513-558-4376 susan.mcmahan@uc.edu

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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Arun Jose, MD, MS    513-558-7451    josean@ucmail.uc.edu   
Contact: Susan Sellers, BSN, CCRP    513-558-4376    susan.mcmahan@uc.edu   
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: Arun Jose, MD, MS University of Cincinnati
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Responsible Party: Arun Jose, Assistant Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04451850    
Other Study ID Numbers: 2019-1371
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases