NCT04451850

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

3.5 years

First QC Date

June 25, 2020

Last Update Submit

March 25, 2025

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HRV via RMSSD

    Change from baseline in Root Mean Squared Successive Differences (RMSSD) measure of Heart Rate variability in patients on targeted therapy

    6 months

Secondary Outcomes (5)

  • Change from baseline in HRV via SDNN

    6 months

  • Correlation with Cardiac Magnetic Resonance Imaging Variables

    6 months

  • Correlation with NTproBNP

    6 months

  • Correlation with REVEAL 2.0 Risk Score

    6 months

  • Correlation with CAMPHOR Quality of Life Score

    6 months

Interventions

Noninvasive actigraphy monitorOTHER

Noninvasive chest-mounted actigraphic device to be worn for 2 hour intervals two times per week during the six month study participation.

Also known as: Polar H10 Heart Rate Monitor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at the University of Cincinnati PAH Clinic in Cincinnati, Ohio

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (3)

  • Heresi GA, Dweik RA. Strengths and limitations of the six-minute-walk test: a model biomarker study in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 May 1;183(9):1122-4. doi: 10.1164/rccm.201012-2079ED. No abstract available.

    PMID: 21531951BACKGROUND

  • Ulrich S, Fischler M, Speich R, Bloch KE. Wrist actigraphy predicts outcome in patients with pulmonary hypertension. Respiration. 2013;86(1):45-51. doi: 10.1159/000342351. Epub 2012 Dec 11.

    PMID: 23234873BACKGROUND

  • Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.

    PMID: 22576635BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Arun Jose, MD, MS

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

June 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)