Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension

NCT04745000 | Completed

• 2 other identifiers: 20-234175F40119C10090
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about activity levels in children with pulmonary hypertension. Pulmonary hypertension is a condition where the pressure in the lungs is higher than normal. This can affect the person's heart. The purpose of this study is to see if measuring activity in children with pulmonary hypertension and comparing it to activity in children without pulmonary hypertension can give their doctor helpful information on how they are feeling and how their treatment is working.

Conditions

Hypertension;Pulmonary;Primary

Keywords

Pediatric; Idiopathic; PAH

Outcome Measures

Primary Outcomes (4)

• Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1

  Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.

  Over 14 Days, reported at Day 15 post baseline (Visit 1)

• Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 2

  Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.

  Over 14 days, reported at about 6 months post-baseline (Visit 2)

• Number of skin irritation adverse events: Visit 1

  Over 14 Days, reported at Day 15 post baseline (Visit 1)

• Number of skin irritation adverse events: Visit 2

  Over 14 days, reported at about 6 months post-baseline (Visit 2)

Secondary Outcomes (24)

• Heart rate: Visit 1

  Over 14 Days, reported at Day 15 post baseline (Visit 1)

• Heart rate: Visit 2

  Over 14 days, reported at about 6 months post-baseline (Visit 2)

• Steps per day: Visit 1

  Over 14 Days, reported at Day 15 post baseline (Visit 1)

• Steps per day: Visit 2

  Over 14 days, reported at about 6 months post-baseline (Visit 2)

• Miles per day: Visit 1

  Over 14 Days, reported at Day 15 post baseline (Visit 1)

Study Arms (2)

Pulmonary Hypertension Participants

Children with Primary Pediatric Pulmonary Arterial Hypertension

Control Participants

Children with a healthy heart and lungs

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

PH patients of PIs seen in cardiology clinics, and a community sample of healthy control participants

You may qualify if:

• Ages 0-6 years at the time of consent
• Current diagnosis of pulmonary hypertension in World Health Organization (WHO) Diagnostic Group 1 as per established clinical criteria including prior catheterization meeting Group 1 criteria
• Panama Functional Class II-IIIa
• Must have been receiving an approved oral endothelin receptor antagonist, calcium channel blocker, phosphodiesterase 5 inhibitor, prostanoid and/or soluble guanylate cyclase stimulator for at least 30 days prior to consent, and has been at the current stable dose, other than weight-based adjustments, for at least 30 days prior to consent
• On stable doses of other medical therapy for 14 days prior to enrollment visit with no dose adjustments, additions, or discontinuations (exception diuretics and anticoagulants; OTC/cold/seasonal allergy medications).

You may not qualify if:

• Diagnosis of congenital diaphragmatic hernia, or a chronic lung disease, such as bronchopulmonary dysplasia, or interstitial lung disease
• Any bone (e.g., osteogenesis imperfecta, ankle, knee, or hip injuries), neuromuscular (e.g., muscular dystrophy), or other pathology that may limit activity (e.g., arthritis)
• Down syndrome
• Use of any medications known to limit activity (e.g., sedative)
• Active infection (may re-screen for enrollment once resolved)
• Any other cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease or condition that, in the opinion of the Investigator, may adversely affect the safety of the participant or interfere with the interpretation of study assessments
• Examples:
• Current diagnosis of uncontrolled sleep apnea as defined by their physician
• Severe renal insufficiency as defined by the requirement for dialysis at screening
• Moderate to severe hepatic dysfunction defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver function tests, greater than or equal to three times the upper limit of normal at screening
• Actively listed for transplantation
• Patient and/or legal guardian has/have an unstable psychiatric condition or is/are mentally incapable of understanding the objectives, nature, or consequences of the trial, or has any condition in which the Investigator's opinion would constitute an unacceptable risk to the participant's safety
• Ages 0-6 years at the time of consent
• In good general health as evidenced by medical history reported by parent/legal guardian during screening and/or available medical records
• Known diagnosis of asthma (controlled or uncontrolled)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Food and Drug Administration (FDA): collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dunbar Ivy, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: February 11, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)