Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension

NCT ID: NCT04745000

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-04-14

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pulmonary Hypertension Participants

Children with Primary Pediatric Pulmonary Arterial Hypertension

No interventions assigned to this group

Control Participants

Children with a healthy heart and lungs

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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).

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

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

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dunbar Ivy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

75F40119C10090

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-2341

Identifier Type: -

Identifier Source: org_study_id