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| ID | Type | Description | Link |
|---|---|---|---|
| 75F40119C10090 | Other Grant/Funding Number | FDA_BAA-18-00123 |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
| Children's Hospital Colorado | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Hypertension Participants | Children with Primary Pediatric Pulmonary Arterial Hypertension | ||
| Control Participants | Children with a healthy heart and lungs |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate: Visit 1 | Measured via Fitbit. | Over 14 Days, reported at Day 15 post baseline (Visit 1) |
| Heart rate: Visit 2 | Measured via Fitbit. |
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Inclusion criteria for children with PAH:
Exclusion criteria for children with PAH:
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:
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
Inclusion criteria for control children:
Exclusion criteria for control children:
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PH patients of PIs seen in cardiology clinics, and a community sample of healthy control participants
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| Name | Affiliation | Role |
|---|---|---|
| Dunbar Ivy, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Over 14 days, reported at about 6 months post-baseline (Visit 2) |
| Steps per day: Visit 1 | Measured via Fitbit and ActiGraph wGT3x-BT. | Over 14 Days, reported at Day 15 post baseline (Visit 1) |
| Steps per day: Visit 2 | Measured via Fitbit and ActiGraph wGT3x-BT. | Over 14 days, reported at about 6 months post-baseline (Visit 2) |
| Miles per day: Visit 1 | Measured via Fitbit. | Over 14 Days, reported at Day 15 post baseline (Visit 1) |
| Miles per day: Visit 2 | Measured via Fitbit. | Over 14 days, reported at about 6 months post-baseline (Visit 2) |
| 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) |
| 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) |
| Active minutes per day: Visit 1 | Measured via Fitbit. | Over 14 Days, reported at Day 15 post baseline (Visit 1) |
| Active minutes per day: Visit 2 | Measured via Fitbit. | Over 14 days, reported at about 6 months post-baseline (Visit 2) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Resting oxygen saturation at Baseline | Baseline |
| Resting oxygen saturation at Visit 2 | About 6 months post baseline |
| Number of PH Participants with Clinical Worsening (CW) Events | End of Study (Up to 12 months post baseline) |
| 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) |
| Natriuretic Peptide Tests - BNP | Brain natriuretic peptide (BNP): a heart failure marker | End of Study (Up to 12 months post baseline) |
| 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) |