Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03516721
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2018-04-16
Brief Title:
Chronotropic Incompetence During Exercise in Obese Adolescents Clinical Implications and Pathophysiology
Sponsor:
Hasselt University
Organization:
Hasselt University
Study Overview
Official Title:
Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CICO
Brief Summary:
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None