Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension

Hypertension;Pulmonary;Primary Clinical Trial

Official title:

A Prospective Study to Investigate the Use of Actigraphy as a Novel, Reliable and Non-invasive Study Endpoint to Facilitate Pediatric Pulmonary Arterial Hypertension Trials and Drug Development for Children Ages 0-6 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745000
• Other study ID #: 20-2341
• Secondary ID: 75F40119C10090
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion criteria for children with PAH:

1. Ages 0-6 years at the time of consent

2. 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

3. Panama Functional Class II-IIIa

4. 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

5. 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).

Exclusion criteria for children with PAH:

1. Diagnosis of congenital diaphragmatic hernia, or a chronic lung disease, such as bronchopulmonary dysplasia, or interstitial lung disease

2. 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)

3. Down syndrome

4. Use of any medications known to limit activity (e.g., sedative)

5. Active infection (may re-screen for enrollment once resolved)

6. 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:

1. Current diagnosis of uncontrolled sleep apnea as defined by their physician

2. Severe renal insufficiency as defined by the requirement for dialysis at screening

3. 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

7. Actively listed for transplantation

8. 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

Inclusion criteria for control children:

1. Ages 0-6 years at the time of consent

2. In good general health as evidenced by medical history reported by parent/legal guardian during screening and/or available medical records

Exclusion criteria for control children:

1. Known diagnosis of asthma (controlled or uncontrolled)

2. Inability to exercise normally either due to an intellectual disability (e.g., Down Syndrome), or a physical disability which could impede activities of daily living.

3. Child 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypertension;Pulmonary;Primary
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado, Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Number of skin irritation adverse events: Visit 1		Over 14 Days, reported at Day 15 post baseline (Visit 1)
Primary	Number of skin irritation adverse events: Visit 2		Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Heart rate: Visit 1	Measured via Fitbit.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Heart rate: Visit 2	Measured via Fitbit.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Steps per day: Visit 1	Measured via Fitbit and ActiGraph wGT3x-BT.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Steps per day: Visit 2	Measured via Fitbit and ActiGraph wGT3x-BT.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Miles per day: Visit 1	Measured via Fitbit.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Miles per day: Visit 2	Measured via Fitbit.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Energy expenditure per day (kcal): Visit 1	Measured via Fitbit and ActiGraph wGT3x-BT.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Energy expenditure per day (kcal): Visit 2	Measured via Fitbit and ActiGraph wGT3x-BT.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Active minutes per day: Visit 1	Measured via Fitbit.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Active minutes per day: Visit 2	Measured via Fitbit.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Count of Activity Bouts: Visit 1	Count of Active bouts recorded and defined by the Actigraphy devices.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Count of Activity Bouts: Visit 2	Count of Active bouts recorded and defined by the Actigraphy devices.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Count of Sedentary Bouts: Visit 1	Count of Sedentary Bouts recorded and defined by the Actigraphy devices.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Count of Sedentary Bouts: Visit 2	Count of Sedentary Bouts recorded and defined by the Actigraphy devices.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Activity Count: Visit 1	Count of Activity Events recorded and defined by the Actigraphy devices.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Activity Count: Visit 2	Count of Activity Events recorded and defined by the Actigraphy devices.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Physical Activity intensity: Visit 1	Number of minutes with "Mild", "Moderate", and "Vigorous" physical activity.	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Secondary	Physical Activity intensity: Visit 1	Number of minutes with "Mild", "Moderate", and "Vigorous" physical activity.	Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary	Resting oxygen saturation at Baseline		Baseline
Secondary	Resting oxygen saturation at Visit 2		About 6 months post baseline
Secondary	Number of PH Participants with Clinical Worsening (CW) Events		End of Study (Up to 12 months post baseline)
Secondary	Number of PH Participants with Genetic Mutations or Positive Genetic tests	Count of PH participants with an observed positive genetic test or genetic mutation.	End of Study (Up to 12 months post baseline)
Secondary	Natriuretic Peptide Tests - BNP	Brain natriuretic peptide (BNP): a heart failure marker	End of Study (Up to 12 months post baseline)
Secondary	Natriuretic Peptide Tests - NT-proBNP)	N-terminal pro b-type natriuretic peptide (NT-proBNP): a heart failure marker	End of Study (Up to 12 months post baseline)