- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02999438
Frailty in Children With Cardiac Disease
July 12, 2023 updated by: Brian Birnbaum, Children's Mercy Hospital Kansas City
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The investigators are studying children with single ventricle physiology, s/p Fontan, patients with heart failure and pulmonary hypertension.
Description
Inclusion Criteria:
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
Exclusion Criteria:
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with hemodynamically significant heart disease
Patients with either:
|
|
Controls
Healthy controls as defined in inclusion- exclusion criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Frailty in children with hemodynamically significant heart disease
Time Frame: 1.5 years
|
1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian Birnbaum, MD, Children's Mercy Hospital Kansas City
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
December 20, 2016
First Posted (Estimated)
December 21, 2016
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16060468
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
US Department of Veterans AffairsCompleted
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
Clinical Trials on Actigraph to check activity levels at home
-
Nonin Medical, IncCompletedCollect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and MethemoglobinemiaUnited States
-
Istanbul University - Cerrahpasa (IUC)Unknown
-
Institut Cancerologie de l'OuestNot yet recruiting
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingPhysical Activity | Lyme Borreliosis | Lyme Borreliosis, Nervous SystemFrance
-
Centre Hospitalier Universitaire de Saint EtienneCompletedPhysical Activity | FibromyalgiaFrance
-
Fondazione Don Carlo Gnocchi OnlusCompletedMultiple Sclerosis
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingPhysical Activity | FibromyalgiaFrance
-
University of FloridaWithdrawnAortic Stenosis | Transcatheter Aortic Valve Replacement | Glutathione Peroxidase ActivityUnited States
-
University Hospital, LimogesRecruitingHematological DiseasesFrance
-
Satellite HealthcareRecruitingEnd Stage Renal Disease | End Stage Kidney DiseaseUnited States