Frailty in Children With Cardiac Disease

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Failure Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Single Ventricle Univentricular Heart Vascular Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actigraph to check activity levels at home

Device

Primary outcomes

Incidence of Frailty in children with hemodynamically significant heart disease

Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Frailty in Children With Cardiac Disease: A Pilot Study

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Dec 21, 2016
Registry last updated: Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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