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Trial record 2 of 1576 for:    REVEAL 2

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
Sponsor:
Information provided by (Responsible Party):
Arun Jose, University of Cincinnati

Tracking Information
First Submitted Date June 25, 2020
First Posted Date June 30, 2020
Last Update Posted Date July 1, 2021
Actual Study Start Date June 1, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 25, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HRV as a Marker of Treatment Response in PAH Arterial Hypertension
Official Title Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients seen at the University of Cincinnati PAH Clinic in Cincinnati, Ohio
Condition Pulmonary Arterial Hypertension
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2020)
35
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Susan McMahan, BSN, RN, CCRP 513-558-4376 susan.mcmahan@uc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04451850
Other Study ID Numbers 2019-1371
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Arun Jose, University of Cincinnati
Original Responsible Party Same as current
Current Study Sponsor University of Cincinnati
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Arun Jose, MD, MS University of Cincinnati
PRS Account University of Cincinnati
Verification Date June 2021