Effects of Isolated LBBB on Maximal Functional Capacity

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized. The main objective of the study is to evaluate the effect of LBBB on maximum functional capacity (objectively evaluated by the maximum oxygen consumption -VO2max- at peak exercise in a cardiopulmonary stress test -CPET-) in subjects with LBBB without known cardiovascular disease and compare these data with controls without LBBB. This is a prospective study that will be carried out in a single centre. All patients with a diagnosis of LBBB and without evidence of structural heart disease in imaging tests will be enrolled. For each candidate with LBBB, one control without LBBB and matched for age, sex, body surface area, and daily physical activity will be selected. All included subjects will undergo a CPET and echocardiography. A sample size estimation [alpha: 0.05, power: 80%, and a clinically significant VO2max difference between groups of at least 10%] of 148 subjects (74 subjects with LBBB + 74 controls) would be necessary to test our hypothesis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05643404
Study type	Observational
Source	Fundación para la Investigación del Hospital Clínico de Valencia
Contact	Marta Peiró, PhD
Phone	+0034 961973536
Email	mpeiro@incliva.es
Status	Recruiting
Phase
Start date	December 22, 2022
Completion date	December 31, 2024

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