Frailty in Children With Cardiac Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 8 - 18 |
| Updated: | 2/1/2018 |
| Start Date: | November 2016 |
| End Date: | June 2018 |
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.
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.
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
We found this trial at
1
site
2401 Gillham Rd
Kansas City, Missouri 64108
Kansas City, Missouri 64108
(816) 234-3000
Phone: 816-234-3255
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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