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Frailty in Children With Cardiac Disease

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ClinicalTrials.gov Identifier: NCT02999438
Recruitment Status : Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Brian Birnbaum, Children's Mercy Hospital Kansas City

Study Description
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Brief 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, 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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Heart Failure Single Ventricle Device: Actigraph to check activity levels at home

Study Design
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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Frailty in Children With Cardiac Disease: A Pilot Study
Study Start Date : November 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Device: Actigraph to check activity levels at home
Controls
Healthy controls as defined in inclusion- exclusion criteria
 Device: Actigraph to check activity levels at home


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Frailty in children with hemodynamically significant heart disease [ Time Frame: 1.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999438


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Brian Birnbaum, MD Children's Mercy Hospital Kansas City
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brian Birnbaum, Physician, Associate Professor of Pediatrics, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02999438    
Other Study ID Numbers: 16060468
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Heart Diseases
Univentricular Heart
Frailty
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities