Frailty in Children With Cardiac Disease

NCT02999438 | Completed

• 1 other identifier: 16060468
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Heart Failure; Single Ventricle

Outcome Measures

Primary Outcomes (1)

• Incidence of Frailty in children with hemodynamically significant heart disease

  1.5 years

Study Arms (2)

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

Interventions

Actigraph to check activity levels at home DEVICE

Controls; Patients with hemodynamically significant heart disease

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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.

  PMID: 32377892 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure; Univentricular Heart

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brian Birnbaum, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

US (1)