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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 December 2023 |
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Main ID: |
NCT04451850 |
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Date of registration:
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25/06/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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HRV as a Marker of Treatment Response in PAH Arterial Hypertension
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Scientific title:
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Heart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH) |
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Date of first enrolment:
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June 1, 2021 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04451850 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Arun Jose, MD, MS |
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Address:
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Telephone:
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513-558-7451 |
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Email:
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josean@ucmail.uc.edu |
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Affiliation:
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Name:
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Susan McMahan, BSN, RN, CCRP |
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Address:
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Telephone:
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513-558-4376 |
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Email:
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susan.mcmahan@uc.edu |
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Affiliation:
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Name:
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Arun Jose, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Other: Noninvasive actigraphy monitor
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Primary Outcome(s)
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Change from baseline in HRV via RMSSD
[Time Frame: 6 months]
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Secondary Outcome(s)
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Correlation with CAMPHOR Quality of Life Score
[Time Frame: 6 months]
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Change from baseline in HRV via SDNN
[Time Frame: 6 months]
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Correlation with NTproBNP
[Time Frame: 6 months]
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Correlation with REVEAL 2.0 Risk Score
[Time Frame: 6 months]
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Correlation with Cardiac Magnetic Resonance Imaging Variables
[Time Frame: 6 months]
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Secondary ID(s)
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2019-1371
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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