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Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology (CICO)

H

Hasselt University

Status

Completed

Conditions

Obesity
Adolescent Obesity

Treatments

Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET

Study type

Interventional

Funder types

Other

Identifiers

NCT03516721
CICO-001

Details and patient eligibility

About

A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly prevalent in obese populations. This phenomenon is also known as chronotropic incompetence (CI). In adult obese individuals, CI is independently related to elevated risk for major adverse cardiovascular events and premature death. Despite the established association between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents with obesity has however deserved no attention, but is important. CI during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. However, whether CI during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. In addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. In this project, we examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between CI and changes in CPET parameters, lactate, catecholamine and potassium concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG recording). In addition, the relation between CI and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.

Enrollment

120 patients

Sex

All

Ages

12 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • aged 12-16 years
  • obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
  • Parental permission

Exclusion criteria

  • Chronic cardiovascular, renal, pulmonary and orthopedic disease

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Obese adolescents
Other group
Treatment:
Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
Lean adolescents
Other group
Treatment:
Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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