Pulmonary HypertensionNCT02999438
Frailty in Children With Cardiac Disease
An observational study of Pulmonary Hypertension and Heart Failure, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- What is being tested?
- Actigraph to check activity levels at home
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The investigators are studying children with single ventricle physiology, s/p Fontan, patients with heart failure and pulmonary hypertension.
Who may be able to join
- SUBJECT/CASE POPULATION herein referred to as Subjects:
- Children and adolescents between the ages of 8.0-17.50 years
- Subjects must be diagnosed with one of the following heart conditions:
- Subjects with single ventricle physiology and Fontan surgery completion at least 6 months prior to study enrollment
- Subjects with diagnosis of heart failure by a cardiologist
- Subjects with a diagnosis of pulmonary arterial hypertension, confirmed by cardiac catheterization, requiring use of at least 1 pulmonary vasodilator or oxygen for their pulmonary hypertension
- CONTROL POPULATION herein referred to as Controls:
- Healthy children and adolescents between the ages of 8.0-17.50 years
Who cannot join
- BOTH SUBJECT/CASE POPULATION AND CONTROL POPULATION:
- Subjects or controls with known severe neurological or respiratory diseases, eating disorders (such as anorexia, bulimia) or physical limitations (wheelchair bound) which may impact their ability to perform study procedures in the opinion of the provider.
- Subjects or controls with tracheostomy and ventilator dependency
- Subjects or controls with unstable angina/ myocardial infarction in the last 4 weeks
- Subjects or controls who are unable to perform 6 continuous minutes of walking, hand-grip dynamometry, or complete questionnaire measures as described.
- SUBJECT/ CASE POPULATION:
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- Subjects with heart transplantation within the past 1 year
- Subject will be excluded if the cardiologist feels that the study is not appropriate for the subject.
- CONTROL POPULATION:
- Controls with any known chronic medical condition requiring some medication over the past 30 days.
- Controls on any chronic prescription medicines for > 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Frailty in Children With Cardiac Disease: A Pilot Study
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and diminished physical activity. The concept of frailty is novel in children. A study in young adult childhood cancer survivors demonstrated increased incidence of frailty in this population along with increased risk of morbidity and mortality. This suggests that frailty as a phenotype has relevance outside of the geriatric age group. Pediatric patients with single ventricle physiology, heart failure and pulmonary artery hypertension- all represent populations with significantly increased risk of mortality, morbidity and decreased quality of life. Currently, such patients are monitored outpatient by serial echocardiograms and blood work that only gives information about end organ damage. But there is no validated tool available to measure global infirmity in such children. Better understanding of the relevance and applicability of frailty in pediatrics may allow for identification of the most vulnerable pediatric cardiac patients and be of value in optimizing their clinical management and improving health outcomes.
- Conditions
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- Being tested
- Actigraph to check activity levels at home
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraph to check activity levels at homeDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with hemodynamically significant heart disease | Patients with either:
1. Single ventricle physiology s/p Fontan
2. Heart failure diagnosed by a cardiologist
3. Pulmonary hypertension diagnosed by cath Receives: Device: Actigraph to check activity levels at home | |
| Controls | Healthy controls as defined in inclusion- exclusion criteria Receives: Device: Actigraph to check activity levels at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Frailty in children with hemodynamically significant heart disease
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Birnbaum, Children's Mercy Hospital Kansas City
- Investigators
- Brian Birnbaum, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999438
- Sponsor's protocol ID
- 16060468
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2016
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Panchangam C, White DA, Goudar S, Birnbaum B, Malloy-Walton L, Gross-Toalson J, Reid KJ, Shirali G, Parthiban A. Translation of the Frailty Paradigm from Older Adults to Children with Cardiac Disease. Pediatr Cardiol. 2020 Jun;41(5):1031-1041. doi: 10.1007/s00246-020-02354-7. Epub 2020 May 6.
PubMed 32377892
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Children With Cardiac Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT02999438
- Acronym / sponsor ID
- 16060468
- Conditions
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and diminished physical activity. The concept of frailty is novel in children. A study in young adult childhood cancer survivors demonstrated increased incidence of frailty in this population along with increased risk of morbidity and mortality. This suggests that frailty as a phenotype has relevance outside of the geriatric age group. Pediatric patients with single ventricle physiology, heart failure and pulmonary artery hypertension- all represent populations with significantly increased risk of mortality, morbidity and decreased quality of life. Currently, such patients are monitored outpatient by serial echocardiograms and blood work that only gives information about end organ damage. But there is no validated tool available to measure global infirmity in such children. Better understanding of the relevance and applicability of frailty in pediatrics may allow for identification of the most vulnerable pediatric cardiac patients and be of value in optimizing their clinical management and improving health outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hemodynamically significant heart disease | – | Device: Actigraph to check activity levels at homePatients with either: 1. Single ventricle physiology s/p Fontan 2. Heart failure diagnosed by a cardiologist 3. Pulmonary hypertension diagnosed by cath |
| Controls | – | Device: Actigraph to check activity levels at homeHealthy controls as defined in inclusion- exclusion criteria |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The investigators are studying children with single ventricle physiology, s/p Fontan, patients with heart failure and pulmonary hypertension.
Key inclusion criteria (8 listed)
- Children and adolescents between the ages of 8.0-17.50 years
- Subjects must be diagnosed with one of the following heart conditions:
- Healthy children and adolescents between the ages of 8.0-17.50 years
Key exclusion criteria (11 listed)
- Subjects or controls with known severe neurological or respiratory diseases, eating disorders (such as anorexia, bulimia) or physical limitations (wheelchair bound) which may impact their ability to perform study procedures in the opinion of the provider.
- Subjects or controls with tracheostomy and ventilator dependency
- Subjects or controls with unstable angina/ myocardial infarction in the last 4 weeks
- Subjects or controls who are unable to perform 6 continuous minutes of walking, hand-grip dynamometry, or complete questionnaire measures as described.
- Subjects with heart transplantation within the past 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actigraph to check activity levels at home | Device | Controls, Patients with hemodynamically significant heart disease |
Primary outcome
Incidence of Frailty in children with hemodynamically significant heart disease
Time frame: 1.5 years
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 14 Jul 2023.
- Derived from this study: PubMed 32377892Panchangam C, White DA, Goudar S, Birnbaum B, Malloy-Walton L, Gross-Toalson J, Reid KJ, Shirali G, Parthiban A. Translation of the Frailty Paradigm from Older Adults to Children with Cardiac Disease. Pediatr Cardiol. 2020 Jun;41(5):1031-1041. doi: 10.1007/s00246-020-02354-7. Epub 2020 May 6.
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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.
Brian Birnbaum, MD principal investigator
Children's Mercy Hospital Kansas City
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 Pulmonary Hypertension and Heart Failure, run by Children's Mercy Hospital Kansas City 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 8 inclusion and 11 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 14 Jul 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?
Incidence of Frailty in children with hemodynamically significant heart disease (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999438, which also lists 1 linked publication.
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 14 Jul 2023.