Hypertension;Pulmonary;PrimaryNCT04745000
Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension
An observational study of Hypertension;Pulmonary;Primary, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension;Pulmonary;Primary
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 14 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: PH patients of PIs seen in cardiology clinics, and a community sample of healthy control participants
Who may be able to join
- 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).
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
- Known diagnosis of asthma (controlled or uncontrolled)
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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
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
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension Participants | Children with Primary Pediatric Pulmonary Arterial Hypertension | |
| Control Participants | Children with a healthy heart and lungs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Number of skin irritation adverse events: Visit 1
Measured: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of skin irritation adverse events: Visit 2
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Secondary outcomes (24)
Heart rate: Visit 1
Measured via Fitbit.
Measured: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Heart rate: Visit 2
Measured via Fitbit.
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Steps per day: Visit 1
Measured via Fitbit and ActiGraph wGT3x-BT.
Measured: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Steps per day: Visit 2
Measured via Fitbit and ActiGraph wGT3x-BT.
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Miles per day: Visit 1
Measured via Fitbit.
Measured: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Miles per day: Visit 2
Measured via Fitbit.
Measured: 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.
Measured: 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.
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Active minutes per day: Visit 1
Measured via Fitbit.
Measured: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Active minutes per day: Visit 2
Measured via Fitbit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Resting oxygen saturation at Baseline
Measured: Baseline
Resting oxygen saturation at Visit 2
Measured: About 6 months post baseline
Number of PH Participants with Clinical Worsening (CW) Events
Measured: 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.
Measured: End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - BNP
Brain natriuretic peptide (BNP): a heart failure marker
Measured: 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
Measured: End of Study (Up to 12 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start11 Feb 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension;Pulmonary;PrimaryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Dunbar Ivy, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745000
- Sponsor's protocol ID
- 20-2341
- Other IDs
- 75F40119C10090
- Status last verified
- May 2023
- First submitted
- 4 Feb 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04745000
- Acronym / sponsor ID
- 20-2341
- Conditions
- Hypertension;Pulmonary;Primary
- Keywords
- Pediatric, Idiopathic, PAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Children's Hospital Colorado
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension Participants | – | –Children with Primary Pediatric Pulmonary Arterial Hypertension |
| Control Participants | – | –Children with a healthy heart and lungs |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- PH patients of PIs seen in cardiology clinics, and a community sample of healthy control participants
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (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.
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (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.
Number of skin irritation adverse events: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of skin irritation adverse events: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
24 secondary outcomes
Heart rate: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Heart rate: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Steps per day: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Steps per day: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Miles per day: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Miles per day: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Energy expenditure per day (kcal): Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Energy expenditure per day (kcal): Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Active minutes per day: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Active minutes per day: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Count of Activity Bouts: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Count of Activity Bouts: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Count of Sedentary Bouts: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Count of Sedentary Bouts: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Activity Count: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Activity Count: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Physical Activity intensity: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Physical Activity intensity: Visit 1
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Resting oxygen saturation at Baseline
Time frame: Baseline
Resting oxygen saturation at Visit 2
Time frame: About 6 months post baseline
Number of PH Participants with Clinical Worsening (CW) Events
Time frame: End of Study (Up to 12 months post baseline)
Number of PH Participants with Genetic Mutations or Positive Genetic tests
Time frame: End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - BNP
Time frame: End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - NT-proBNP)
Time frame: End of Study (Up to 12 months post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Hypertension;Pulmonary;Primary
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
Enrolling by invitationPhase 3
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
PAH, Pulmonary Hypertension
RecruitingPhase 1
: Vascular Function in Health and Disease
Chronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension
RecruitingObservational study
Hormonal, Metabolic, and Signaling Interactions in PAH
Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dunbar Ivy, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension;Pulmonary;Primary, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1 (time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.