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

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:

  1. Single ventricle physiology s/p Fontan
  2. Heart failure diagnosed by a cardiologist
  3. Pulmonary hypertension diagnosed by cath
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

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.

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